- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03164460
Stereotactic Body Radiation Therapy or Intensity Modulated Radiation/Proton Therapy in Treating Patients With Recurrent Head and Neck Cancer
Phase II Randomized Trial of Stereotactic Onco-Ablative Reirradiation Versus Conventionally Fractionated Conformal Radiotherapy for Patients With Small Inoperable Head and Neck Tumors (SOAR-HN)
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To compare the 2-year rate of Common Terminology Criteria for Adverse Events (CTCAE)-4.0 grade 3 or higher toxicity at 2 years between the two treatment arms.
SECONDARY OBJECTIVES:
I. To compare the 2-year locoregional failure free survival (LFFS) in patients being treated with reirradiation with either stereotactic ablative radiotherapy (SBRT) versus intensity modulated radiation therapy/intensity modulated proton therapy (IMRT/IMPT).
II. To determine if there is any difference in local control, progression-free survival, and overall survival between the two arms.
III. To compare toxicity using Common Terminology Criteria for Adverse Events (CTCAE)-4.0 and Performance Status Scale-HN (Head and Neck).
IV. To compare patient reported outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI), MD Anderson Dysphagia Inventory (MDADI), Functional Assessment of Cancer Therapy (FACT)-HN, ACT-HN Symptom Index (FACT-HNSI), MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT), for skull base only, Anterior Skull BASE Questionnaire (ASBQ), for skull base only, Brief Fatigue Inventory (BFI), Telephone Interview for Cognitive Status (TICS), Performance Status Scale For Head and Neck Cancer Patients (PSS-HN), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem version (V)2.0 (WPAI:SHP), and University of Michigan Xerostomia-Related Quality of Life Scale, Xerostomia and Health Questionnaire (European Quality of Life Five Dimension Three Level [EQ-5D-3L]).
V. Quality-Adjusted-Life-Years (QALY) comparison between IMPT and IMRT. VI. Compare cost-benefit economic analysis of treatment. VII. Perform dosimetric analysis and compare correlates of critical structures.
EXPLORATORY OBJECTIVES:
I. To assess potential differences between patients on study and patients who were considered eligible for randomized, were randomized to a treatment arm, but may have dropped out of the study for other reasons after being randomized to; or were denied insurance coverage for the treatment arm she/he was randomized.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients undergo SBRT every other day for a total of 5 treatments.
GROUP II: Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.
After completion of study treatment, patients are followed up at 2-3 months, every 3 months for 1 year, and then every 3-4 months for up to 2 years.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jack Phan, MD, PHD
- Phone Number: 713-563-2300
- Email: jphan@mdanderson.org
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Jack Phan, MD
- Phone Number: 713-563-2300
- Email: jphan@mdanderson.org
-
Principal Investigator:
- Jack Phan, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer
- Not eligible for surgery for recurrence or poor surgical candidate
- Gross disease apparent on imaging (magnetic resonance imaging [MRI] or computed tomography [CT])
- 1-3 sites of recurrence (< 60 cc per site, total volume < 100 cc)
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
- Negative pregnancy test for women of child bearing potential
Exclusion Criteria:
- Patients who are pregnant or breast feeding
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
- a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
- b) No myocardial infarction within 3 months of registration
- Widely metastatic disease (oligometastatic disease acceptable)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I (SBRT)
Patients undergo SBRT every other day for a total of 5 treatments.
|
Undergo SBRT
Other Names:
|
Experimental: Group II (IMRT/IMPT)
Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.
|
Undergo IMRT/IMPT
Other Names:
Undergo IMRT/IMPT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of grade 3+ toxicity (Tox3+) assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame: At 2 years
|
Will use the methods of Gooley et al. to estimate the cumulative incidence of Tox3+, as well as competing-risk regression to model cumulative incidence of Tox3+ while treating death not related to Tox3+ as a competing event.
The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between patient groups.
The chi-square test or the Fisher's exact test will be applied to evaluate the association between two categorical variables.
Logistic regression models will be used to evaluate the effects of the important patient clinical factors including treatment on TOX3+.
|
At 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local control defined as absence of local failure
Time Frame: Up to 2 years
|
The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between patient groups.
The chi-square test or the Fisher's exact test will be applied to evaluate the association between two categorical variables.
Logistic regression models will be used to evaluate the effects of the important patient clinical factors including treatment on TOX3+.
|
Up to 2 years
|
Local failure free survival (LFFS) defined as failure (recurrence or progression) within the prescribed radiation field, including failure within 2 cm of the radiation field
Time Frame: From treatment initiation until local failure or death from any cause, assessed at 2 years
|
Will be estimated using the method of Kaplan and Meier.
Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
Proportional hazards regression may be employed for multivariate analysis on time-to-event outcomes.
|
From treatment initiation until local failure or death from any cause, assessed at 2 years
|
Incidence of acute grade 3 or higher toxicity assessed by CTCAE
Time Frame: Up to 90 days after completion of radiation therapy
|
The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between patient groups.
The chi-square test or the Fisher's exact test will be applied to evaluate the association between two categorical variables.
Logistic regression models will be used to evaluate the effects of the important patient clinical factors including treatment on TOX3+.
|
Up to 90 days after completion of radiation therapy
|
Incidence of late grade 3 or higher toxicity assessed by CTCAE
Time Frame: 90 days up to 2 years
|
The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between patient groups.
The chi-square test or the Fisher's exact test will be applied to evaluate the association between two categorical variables.
Logistic regression models will be used to evaluate the effects of the important patient clinical factors including treatment on TOX3+.
|
90 days up to 2 years
|
Progression free survival (PFS)
Time Frame: From treatment initiation until an LFFS event, or occurrence, recurrence, or progression of distant metastases, whichever occurs first, assessed up to 2 years
|
PFS event is defined as an LFFS event, or occurrence, recurrence or progression of distant metastases.
Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
Proportional hazards regression may be employed for multivariate analysis on time-to-event outcomes.
|
From treatment initiation until an LFFS event, or occurrence, recurrence, or progression of distant metastases, whichever occurs first, assessed up to 2 years
|
Overall survival
Time Frame: From treatment initiation until time to death from any cause, assessed up to 2 years
|
Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
Proportional hazards regression may be employed for multivariate analysis on time-to-event outcomes.
|
From treatment initiation until time to death from any cause, assessed up to 2 years
|
Patient reported outcomes (PROs)
Time Frame: Up to 2 years
|
Generalized linear models for the repeated measures analysis will be performed to assess the change in PROs overtime with important covariates including treatment in the models.
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Up to 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jack Phan, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-1065 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-01190 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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