Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients
NCT01000415 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 824
Last updated 2010-06-24
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 treatment (given cis-platinum/carboplatin during radiation-concurrent chemoradiation)in specific group of cervical cancer patients (stage Ib2-early IIb)
* to evaluate quality of life in both group of patients(standard treatment vs.experimental group)
Conditions
Interventions
- OTHER
-
Neoadjuvant chemotherapy followed by surgery
Cisplatin 50 mg/m2 (in the vein)on day 1 of each 23 day cycle plus gemcitabine 1000 mg/m2 (in the vein) on day 1 and day 8, for 3 cycles: until progression or unacceptable toxicity develops.
Sponsors & Collaborators
-
National Research Council of Thailand
collaborator OTHER_GOV -
Clinical Research Collaborative Network
collaborator NETWORK -
Thai Gynecologic Oncology Collaborative Group
lead NETWORK
Principal Investigators
-
Saibua B. Chichareon, MD. · Thai Gynecologic Oncology Collaborative Group (TGOC)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2013-09-30
- Completion
- 2018-06-30
Countries
- Thailand
Study Locations
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