Efficacy and Safety Study of Concurrent Chemoradiation Therapy to Treat Locally Advanced Cervical Cancer

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for both patients and physicians. Weekly carboplatin may have similar efficacy with weekly cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in patients with locally advanced cervical cancer.

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

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Boryung Pharmaceutical Co., Ltd
• Treatments: Carboplatin; Cisplatin

Criteria

Inclusion Criteria:

• Previously untreated, histologically confirmed cervical cancer

• One of following histologic types Squamous carcinoma, adenocarcinoma, adenosquamous carcinoma

• Age: 20-75 years

• GOG performance status: 0-2

• Adequate organ function Bone marrow: WBC ≥ 3,000/mm3, ANC ≥ 1,500/mm3, Platelet ≥ 100X103/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine < 1.25 × UNL, Liver : AST, ALT < 3 × UNL, T- bilirubin < 1.5 mg/ mm3

• Contraception during study treatment

• Informed consent

Exclusion Criteria:

• Previous chemotherapy or pelvic radiation therapy

• Hormone therapy within 4 weeks

• Concomitant malignancy within 5 years except cured basal cell carcinoma of skin

• Uncontrolled medical disease

• Pregnant or lactating woman

• Etc.