Adjuvant Chemotherapy for Locally Advanced Cervical Cancer

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Siriwan Tangjitgamol, MD
• Collaborators: Bhumibol Adulyadej Hospital; Chiang Mai University; Chonburi Cancer Hospital; Chulalongkorn University; Health Intervention and Technology Assessment Program; Lampang Cancer Hospital; Lopburi Cancer Hospital; National Research Council of Thailand; Navamindradhiraj University; Prince of Songkla University; Rajburi Hospital; Ubonratchathani Cancer Hospital; Udonthani Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel

Criteria

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