NCT02036164

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Siriwan Tangjitgamol, MD · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Uterine Cervical Cancer

Interventions

Type	Name	Description
RADIATION	Pelvic radiation	Radiation: * Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks * Brachytherapy 30-35 Gy for 4-5 times
DRUG	Cisplatin	Cisplatin 40 mg/m2 i.v.
DRUG	Paclitaxel	Paclitaxel 175 mg m2 i.v.
DRUG	Carboplatin	Carboplatin AUC 5 i.v.

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-01-01
• Completion: 2019-01-01
• First posted: 2014-01-14
• Last updated: 2017-04-06

Locations

11 sites across 1 country: Thailand