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

Asan Medical Center

Status and phase: Terminated; Phase 3

Conditions: Cervical Cancer

Treatments: Drug: Carboplatin; Radiation: Radiation therapy; Drug: Cisplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01461772

CCRTCICA-CXCA

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

CCRT weekly carboplatin

Experimental group

Description:

Concurrent chemoradiation therapy with weekly carboplatin

Treatment:

Radiation: Radiation therapy

Drug: Carboplatin

CCRT weekly cisplatin

Active Comparator group

Description:

Concurrent chemoradiation therapy with weekly cisplatin

Treatment:

Radiation: Radiation therapy

Drug: Cisplatin