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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cervical Cancer Stage IVB

Intervention / Treatment
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* Radiation: Chemotherapy,radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-proven, invasive carcinoma of the cervix(squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma ) KPS≥70 FIGO stage IVB Age: 18-70 ECOG (Eastern Cooperative Oncology Group) : 0-2 The expected survival time is >6 months Chemotherapy and radiation have not been done before 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) Able to understand this study and have signed informed consent. Exclusion Criteria: Prior hysterectomy Metastases lesions are confirmed by pathology or image and are excluded as the second primary neoplasm Patients with brain metastasis or disseminated peritoneal metastasis Female in pregnancy or lactating Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy) History of major psychiatric disorder Persons with physical or mental illness, without civil capacity or with limited capacity for civil conduct Patient with any other disease or condition is a contraindication for chemoradiotherapy The researchers consider the patient not appropriate to be enrolled

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy,radiotherapy<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Cancer, Radiotherapy, Chemotherapy, stage IVB cervical cancer