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

Phase 3TerminatedNCT01461772

Asan Medical Center21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cervical Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Response rate

Time frame: 3 months after completion of study treatment

Secondary Outcomes

Number of patients with adverse events as a measure of safety and tolerability

Time frame: Before each chemotherapy, an average of 1 week

Disease-free survival

Time frame: 2 years after completion of study treatment

Overall survival