Efficacy and Safety Study of Concurrent Chemoradiation Therapy to Treat Locally Advanced Cervical Cancer
NCT01461772 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2017-05-31
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.
Conditions
Interventions
- RADIATION
-
Radiation therapy
pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)
- DRUG
-
carboplatin 130mg/m2BSA on day 1,8,15,22,29,and 36
- DRUG
-
Cisplatin 40mg/m2BSA on day 1,8,15,22,29,and 36
Sponsors & Collaborators
-
Boryung Pharmaceutical Co., Ltd
collaborator INDUSTRY -
Asan Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-12-31
- Primary Completion
- 2014-05-31
- Completion
- 2014-05-31
Countries
- South Korea
Study Locations
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