Adjuvant Chemotherapy for Locally Advanced Cervical Cancer

Study Overview
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Brief Summary
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Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We will investigate if ACT has survival benefit over CCRT alone.

Detailed Description
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Concurrent chemoradiation (CCRT) is the standard treatment for cervical cancer of FIGO stage IIB-IVA or so called locally advanced cervical cancer (LACC). However, failure rate after treatment is still as high as 30% to 40%. This is a multi-center randomized controlled trial which evaluates whether adjuvant chemotherapy (ACT) after CCRT will improve treatment outcome comparing to CCRT alone.

Official Title
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Randomized Controlled Trial Comparing Concurrent Chemoradiation Versus Concurrent Chemoradiation Followed by Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients

Conditions
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Uterine Cervical Cancer

Intervention / Treatment
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* Radiation: Pelvic radiation
* Drug: Cisplatin
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 years Cervical cancer FIGO stage IIB-IVA Histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma ECOG performance status 0-2 No history of other cancer except basal cell carcinoma Adequate bone marrow function (WBC > or = 3,000/mm3, granulocytes > or = 1,500/mm3, platelet count > or = 100,000/mm3) Bilirubin < 1.5 folds, SGOT/ SGPT < 1.5 folds of normal limit, creatinine clearance > or = 40 mg/dl Consent to participate Exclusion Criteria: Para-aortic lymph node enlargement > 1 cm or suspicious for cancer metastasis from CT or MRI Adnexal mass from physical examination or imaging study Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection. Pregnancy or lactation

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Concurrent chemoradiation<br>Radiation: Radiation Therapy External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin - Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy | Radiation: Pelvic radiation<br>* Radiation: Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks Brachytherapy 30-35 Gy for 4-5 times<br>* Other names: External beam pelvic radiation therapy and brachytherapy;Drug: Cisplatin<br>* Cisplatin 40 mg/m2 i.v.<br>* Other names: - Platin®;|
| Experimental: Concurretn chemoradiation plus adjuvant chemotherapy<br>Radiation: Radiation Therapy External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine Vaginal brachytherapy for 4-5 fractions Chemotherapy: Cisplatin, paclitaxel, carboplatin Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel | Radiation: Pelvic radiation<br>* Radiation: Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks Brachytherapy 30-35 Gy for 4-5 times<br>* Other names: External beam pelvic radiation therapy and brachytherapy;Drug: Cisplatin<br>* Cisplatin 40 mg/m2 i.v.<br>* Other names: - Platin®;Drug: Paclitaxel<br>* Paclitaxel 175 mg m2 i.v.<br>* Other names: - Anzatax®;Drug: Carboplatin<br>* Carboplatin AUC 5 i.v.<br>* Other names: - Kemocarb®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | 3-year progression free survival | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 3-year overall survival | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced cervical cancer, Concurrent chemoradiation, Adjuvant chemotherapy