Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer

Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer: A Prospective, Single Arm, Phase II Clinical Trial

This is a prospective, single arm, phase II trail to assess the effect of primary lesion radiotherapy in the treatment of stage IVB cervical cancer on the basis of systemic chemotherapy.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer Stage IVB
• Intervention / Treatment: Radiation: Chemotherapy,radiotherapy

Detailed Description

Because of the apparent heterogeneity of stage IVB cervical cancer, at present there is no standard treatment.

This is a Phase II, single-center, single-arm, study of systemic chemotherapy plus lesion radiotherapy for primary stage IVB cervical cancer.

The primary objective of the study is to test the hypothesis that primary lesion radiotherapy leads to an improvement in progression-free survival time (PFS)for stage IVB cervical cancer.

For those patients under the clinical management of the recruiting investigator, the investigator will review the patient's medical records and determine if they would be a candidate for the study.

Upon confirmation of all eligibility criteria, the subject will be enrolled.Patients with beyond abdominal pelvic lymph node metastasis will first undergo 2 cycle systemic chemotherapy（TP/TC），then to evaluate the efficacy of chemotherapy, and for patients with chemotherapy effective（CR+PR+SD) followed by the primary lesion of regional radiotherapy (external irradiation plus brachytherapy)，concurrent chemotherapy （TP/TC） may be given according to the patients tolerant，finally, the patient will complete a total of 6 cycles of chemotherapy（TP/TC）.Distant metastasis of lymph node areas (e.g., supraclavicular, axillary, mediastinum, etc.) will be radiation after radiotherapy at the primary site according to patients tolerant.Patients with stage IVB cervical cancer with hematogenous metastasiswill first undergo 4 cycle systemic chemotherapy（TP/TC），then to evaluate the efficacy of chemotherapy, and for patients with chemotherapy effective（CR+PR+SD) followed by the primary lesion of regional radiotherapy (external irradiation plus brachytherapy)，concurrent chemotherapy （TP/TC） may be given according to the patients tolerant，finally, the patient will complete a total of 6 cycles of chemotherapy（TP/TC），after the primary radiotherapy, the treatment regimen for distant metastasis will be determined by MDT discuss or consultation.Quality of life will be evaluated before and after treatment. During therapy, the patient will have a weekly physical exam, vital signs collected, evaluation for pain, and review any side effects.

Subjects will undergo a post treatment follow-up period after completion of their radiation therapy. During this follow-up period, subjects will return for a medical and history review with a complete physical examination, review of any side effects, evaluation for outcomes and toxicity, and QoL.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HanMei Lou, M.A.; Phone Number: Telephone: 0086-571-88122038; Email: louhanmei@zjcc.org.cn
• Study Contact Backup: Name: ZhuoMin Yin; Phone Number: 0086-571-88122032; Email: yinzm@zjcc.org.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: ZhuoMin Yin; Phone Number: 0086-571-88122032; Email: yinzm@zjcc.org.cn
      • Contact: HanMei Lou, M.A.; Phone Number: 0086-571-88122038; Email: louhanmei@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Biopsy-proven, invasive carcinoma of the cervix(squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma )
2. KPS≥70
3. FIGO stage IVB
4. Age: 18-70
5. ECOG (Eastern Cooperative Oncology Group) : 0-2
6. The expected survival time is >6 months
7. Chemotherapy and radiation have not been done before
8. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function)
9. Able to understand this study and have signed informed consent.

Exclusion Criteria:

1. Prior hysterectomy
2. Metastases lesions are confirmed by pathology or image and are excluded as the second primary neoplasm
3. Patients with brain metastasis or disseminated peritoneal metastasis
4. Female in pregnancy or lactating
5. Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy)
6. History of major psychiatric disorder
7. Persons with physical or mental illness, without civil capacity or with limited capacity for civil conduct
8. Patient with any other disease or condition is a contraindication for chemoradiotherapy
9. The researchers consider the patient not appropriate to be enrolled

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: Chemotherapy,radiotherapy; Lymphatic metastasis patients undergoing 2 cycles of chemotherapy(TP/TC), blood metastasis patients receiving 4 cycles of chemotherapy, then patients with therapeutic evaluation for (CR+PR+SD) will undergo the radiotherapy (external irradiation plus brachytherapy) for primary lesion area , all patients completed total 6 cycles of chemotherapy (TP/TC), and finally will determine the of treatment plans of metastasis areas based on tolerance and discuss results by MDT.

Radiation: Chemotherapy,radiotherapy; Pelvic,pelvic-inguinal,or extended field radiotherapy：Therapy 45 - 50 Gy in 1.7 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks for PTV Brachytherapy: Therapy 5-6 fractions of 4-6Gy prescribed to the high-risk CTV or A piont.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival time, PFS	Progression-free survival will be evaluated	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients with Adverse Events as a Measure of Safety	To quantify rates of acute hematologic, gastrointestinal, and genitourinary toxicity	2 years
Objective Response Rates, ORR	Objective Response Rates will be evaluated	2 years
Overall survival	Overall survival will be evaluated	2 years
Ranking Quality of Life of Patients	To measure health-related quality of life based on the cancer-specific EORTC-QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and cervical cancer module(CX24).	2 years
Screening for potentially curable primary stage IVB cervical cancer	By follow-up data,screening for potentially curable primary stage IVB cervical cancer	2 years

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: HanMei Lou, M.A., Zhejiang Cancer Hospital; Principal Investigator: ZhuoMin Yin, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Anticipated): October 31, 2018
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: May 28, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Radiotherapy; Cervical Cancer; Chemotherapy; stage IVB cervical cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: ZJCH-2017-CRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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