Efficacy and Safety Study of Concurrent Chemoradiation Therapy to Treat Locally Advanced Cervical Cancer

Study Overview
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Brief Summary
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Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for both patients and physicians. Weekly carboplatin may have similar efficacy with weekly cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in patients with locally advanced cervical cancer.

Official Title
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Comparison of Concurrent Chemoradiation Therapy With Weekly Cisplatin and Concurrent Chemoradiation Therapy With Weekly Carboplatin in Locally Advanced Cervical Cancer: Phase III Multicenter Prospective Randomized Controlled Trial

Conditions
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Cervical Cancer

Intervention / Treatment
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* Radiation: Radiation therapy
* Drug: Carboplatin
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously untreated, histologically confirmed cervical cancer One of following histologic types Squamous carcinoma, adenocarcinoma, adenosquamous carcinoma Age: 20-75 years GOG performance status: 0-2 Adequate organ function Bone marrow: WBC ≥ 3,000/mm3, ANC ≥ 1,500/mm3, Platelet ≥ 100X103/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine < 1.25 × UNL, Liver : AST, ALT < 3 × UNL, T- bilirubin < 1.5 mg/ mm3 Contraception during study treatment Informed consent Exclusion Criteria: Previous chemotherapy or pelvic radiation therapy Hormone therapy within 4 weeks Concomitant malignancy within 5 years except cured basal cell carcinoma of skin Uncontrolled medical disease Pregnant or lactating woman Etc.

Ages Eligible for Study
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Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CCRT weekly carboplatin<br>Concurrent chemoradiation therapy with weekly carboplatin | Radiation: Radiation therapy<br>* pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)<br>Drug: Carboplatin<br>* carboplatin 130mg/m2BSA on day 1,8,15,22,29,and 36<br>|
| Active Comparator: CCRT weekly cisplatin<br>Concurrent chemoradiation therapy with weekly cisplatin | Radiation: Radiation therapy<br>* pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)<br>Drug: Cisplatin<br>* Cisplatin 40mg/m2BSA on day 1,8,15,22,29,and 36<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 3 months after completion of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events as a measure of safety and tolerability |  | Before each chemotherapy, an average of 1 week | 
| Disease-free survival |  | 2 years after completion of study treatment | 
| Overall survival |  | 2 years after completion of study treatment | 
| Quality of life |  | 3 months after completion of study treatment |