Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients
NCT ID: NCT01000415
Last Updated: 2010-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
824 participants
INTERVENTIONAL
2009-06-30
2018-06-30
Brief Summary
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* 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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cisplatin plus gemcitabine
Experimental arm: neoadjuvant chemotherapy (cisplatin plus gemcitabine) followed by surgery Control arm: concurrent chemoradiation (cisplatin/carboplatin)during standard radiation
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Underlying disease not fit for surgery
* Psychological problem
* Obvious pelvic/para-aortic node involvement
* Pregnancy
* HIV positive
* History of bowel obstruction
18 Years
60 Years
FEMALE
No
Sponsors
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National Research Council of Thailand
OTHER_GOV
Clinical Research Collaborative Network
NETWORK
Thai Gynecologic Oncology Collaborative Group
NETWORK
Responsible Party
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Thai Gynecologic Oncology Collaborative Group
Principal Investigators
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Saibua B. Chichareon, MD.
Role: PRINCIPAL_INVESTIGATOR
Thai Gynecologic Oncology Collaborative Group (TGOC)
Locations
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Gynecologic Oncology Unit, Department of Obstertrics and Gynecology, Faculty of medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Termrungruanglert W, Tresukosol D, Vasuratna A, Sittisomwong T, Lertkhachonsuk R, Sirisabya N. Neoadjuvant gemcitabine and cisplatin followed by radical surgery in (bulky) squamous cell carcinoma of cervix stage IB2. Gynecol Oncol. 2005 May;97(2):576-81. doi: 10.1016/j.ygyno.2005.01.048.
Other Identifiers
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ECPSU-522231012
Identifier Type: -
Identifier Source: secondary_id
TGOC-03
Identifier Type: -
Identifier Source: org_study_id
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