Status:
TERMINATED
Efficacy and Safety Study of Concurrent Chemoradiation Therapy to Treat Locally Advanced Cervical Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Boryung Pharmaceutical Co., Ltd
Conditions:
Cervical Cancer
Eligibility:
FEMALE
20-75 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01461772
Start Date
December 1 2009
End Date
May 1 2014
Last Update
May 31 2017
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736