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

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.

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