Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer

Study Overview
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Brief Summary
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Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally advanced cervical cancers.

Detailed Description
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This study is to compare the compliance, toxicity, response and survival rate between concurrent chemoradiation with weekly cisplatin 40mg/m2 and three-week cisplatin 75mg/m2 in patients with advanced cervical cancer. Patients with primary untreated invasive squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix from stage IIB to IVA were enrolled. Patients with histologically proven locoregionally advanced cervical cancer will be randomized into two treatment arm; Arm I, concurrent chemoradiation with weekly cisplatin 40mg/m2 for six times; Arm II, concurrent chemoradiation with three-week cisplatin 75mg/m2 for three times. The compliance and toxicity during the chemoradiation is the primary endpoint. Response rate and the overall survival will be analyzed as secondary endpoints.

Official Title
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Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer

Conditions
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Cervical Cancers

Intervention / Treatment
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* Radiation: radiation
* Drug: weekly cisplatin
* Drug: tri-weekly cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven cervical cancer Squamous, Adenosquamous, Adeno carcinoma cell type International Federation of Gynecologic Oncology (FIGO) stage IIB - IVA Gynecologic Oncology Group (GOG) performance status 0 - 2 Exclusion Criteria: Previous history of chemotherapy or radiation History of other cancer Hypersensitivity to platinum agents Pregnancy Serious medical disease

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: weekly cisplatin<br>Weekly cisplatin 40mg/m2 during radiation therapy | Radiation: radiation<br>* radiation with cisplatin 40mg/m2, 6 cycles, every week<br>Drug: weekly cisplatin<br>* weekly cisplatin 40mg/m2, 6 cycles<br>* Other names: Cisplatin;|
| Experimental: tri-weekly cisplatin<br>cisplatin 75mg/m2 three cycles, every 3 weeks | Radiation: radiation<br>* radiation with cisplatin 40mg/m2, 6 cycles, every week<br>Drug: tri-weekly cisplatin<br>* cisplatin 75mg/m2, 3cycles, every 3 weeks<br>* Other names: Cisplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance | Percentage of completed cycles of scheduled chemotherapy in each arm Percentage of grade III and IV toxicity Delayed radiation time due to toxicity | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | 5 year progression free survival 5 year survival rate | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Neoplasm, chemoradiation, compliance, toxicity