Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma

The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.

Study Overview

• Status: Completed
• Conditions: Hodgkin's Lymphoma
• Intervention / Treatment: Drug: Adriamycin®; Drug: Vinblastine; Drug: Nitrogen Mustard; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Bleomycin; Drug: Etoposide; Drug: Prednisone; Biological: G-CSF; Procedure: Radiotherapy

Detailed Description

Treatment Plan Description:

Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9

Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)

Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11

Prednisone* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12

G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

* Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center
    • San Diego, California, United States, 92123
      • Rady Children's Hospital San Diego
  • Maine
    • Portland, Maine, United States, 04102-3175
      • Maine Children's Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is less than or equal to 21 years of age
• Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma
• Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.

Exclusion Criteria:

• Patients with favorable risk features
• Patients with unfavorable risk features
• Patients who have received prior therapy for Hodgkin lymphoma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All Participants; Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Drug: Adriamycin®; Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.; Other Names: Doxorubicin; Drug: Vinblastine; Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.; Other Names: Velban®; Drug: Nitrogen Mustard; Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.; Other Names: Mustargen®; Mechlorethamine Hydrochloride; Drug: Cyclophosphamide; May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.; Other Names: Nitrogen Mustard Derivative; Drug: Vincristine; Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.; Other Names: Velban®; Drug: Bleomycin; Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.; Other Names: Blenoxane®; Drug: Etoposide; Given IV on Days 1 and 2 of weeks 1-10.; Other Names: VP-16; Vepesid®; Drug: Prednisone; Given PO every other day of weeks 1-12.; Other Names: Synthetic congener of hydrocortisone; Biological: G-CSF; Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).; Other Names: Filgrastim; Neupogen®; Procedure: Radiotherapy; Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.; Other Names: Radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year Event-Free Survival Probability	The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Failure Rate Within Radiation Fields	Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).	3 years
Local and Distant Failure for Children Treated With Tailored-field Radiation	The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.	from first enrollment date up to 3 years follow-up
Prognostic Factors for Treatment Failure: Age	Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.	5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
Patient Quality of Life (QoL), PedsQL v.4.0: Total Score	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Total Score	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Nausea	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Worry	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), PedsQL v.3.0: Communication	Patient QOL will be measured at multiple time points to assess the patient's functioning. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Patient Quality of Life (QoL), Symptom Distress Scale	The patient's degree of discomfort from specific treatment-related symptoms across multiple time points. Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication	Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication	Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.	At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score	Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning	Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health	Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning	Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning	Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning	Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score	Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt	Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea	Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety	Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety	Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry	Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems	Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance	Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication	Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores. Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.	6 months after the completion of therapy
3-year Event-free Survival (EFS) Probability	Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.	3 years
3-year Overall Survival (OS) Probability	Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.	3-years
3-year Local Failure-free Survival Probability	Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.	3 years
Toxicities With Grade >1	Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.	3 years
Prognostic Factors for Treatment Failure: Gender	Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.	3 years follow-up
Prognostic Factors for Treatment Failure: Histology	Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.	3 years follow-up
Prognostic Factors for Treatment Failure: Stage	Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage <III showed a better outcome but was not statistically significant.	5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)	Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized.	1, 2, 5, and 10 years post therapy
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)	Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome.	1, 2, 5, and 10 years post therapy
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)	Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results.	1, 2, 5, and 10 years post therapy
Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)	For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings.	1, 2, 5, and 10 years post therapy

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Jamie Flerlage, MD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2006
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: July 13, 2006
• First Submitted That Met QC Criteria: July 13, 2006
• First Posted (Estimated): July 14, 2006

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hodgkin's Disease
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Etoposide; Prednisone; Doxorubicin; Vincristine; Hydrocortisone; Bleomycin; Vinblastine; Mechlorethamine; Nitrogen Mustard Compounds
• Other Study ID Numbers: HOD05; NCI-2011-01253 (Registry Identifier: NCI Clinical Trial Registration Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No