Status:
UNKNOWN
Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients
Lead Sponsor:
Thai Gynecologic Oncology Collaborative Group
Collaborating Sponsors:
National Research Council of Thailand
Clinical Research Collaborative Network
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-60 years
Phase:
PHASE3
Brief Summary
The purpose of this study is: * to compare the effectiveness between the new strategy of treatment (given cis-platinum plus gemcitabine-neoadjuvant chemotherapy followed by surgery),and standard trea...
Detailed Description
According to FIGO classification of cervical cancer, stage Ib2 was classified as clinically visible lesion more than 4.0 cm in greatest dimension and stage IIb was classified tumor invades parametrium...
Eligibility Criteria
Inclusion
- Cervical cancer patients with FIGO stage Ib2-early IIb
- Pathological proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma
- ECOG performance status 0-1
- No previous treatment for cervical cancer
- Acceptable hematological,renal,liver function
Exclusion
- Previous history of cancer
- Underlying disease not fit for surgery
- Psychological problem
- Obvious pelvic/para-aortic node involvement
- Pregnancy
- HIV positive
- History of bowel obstruction
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
824 Patients enrolled
Trial Details
Trial ID
NCT01000415
Start Date
June 1 2009
End Date
June 1 2018
Last Update
June 24 2010
Active Locations (1)
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1
Gynecologic Oncology Unit, Department of Obstertrics and Gynecology, Faculty of medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand, 90110