Efficacy and Safety Study of Concurrent Chemoradiation Therapy to Treat Locally Advanced Cervical Cancer
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Radiation therapy Type: Radiation
Name: Carboplatin Type: Drug
Name: Cisplatin Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Female
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.
Location
Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Joo-Hyun Nam, M.D., Ph.D. - +82-2-3010-3633 - jhnam@amc.seoul.kr
Start Date
December 2009
Completion Date
November 2015
Sponsors
Asan Medical Center
Source
Asan Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page