Adjuvant Chemotherapy for Locally Advanced Cervical Cancer
Randomized Controlled Trial Comparing Concurrent Chemoradiation Versus Concurrent Chemoradiation Followed by Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients
Lead SponsorNavamindradhiraj University
Indication/ConditionUterine Cervical Cancer
Intervention/Treatmentpaclitaxel carboplatin cisplatin ...
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.
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.
Radiation: Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks Brachytherapy 30-35 Gy for 4-5 times
Cisplatin 40 mg/m2 i.v.
Paclitaxel 175 mg m2 i.v.
Carboplatin AUC 5 i.v.
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: 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
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