Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix
NCT ID: NCT00191100
Last Updated: 2009-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
515 participants
INTERVENTIONAL
2002-05-31
2008-04-30
Brief Summary
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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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1
Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Gemcitabine 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, intravenous (IV), day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
Gemcitabine
Cisplatin
Brachytherapy
Brachytherapy, 30-35 Gy over 1 week
Pelvic radiation
Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
2
Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Cisplatin
Brachytherapy
Brachytherapy, 30-35 Gy over 1 week
Pelvic radiation
Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Interventions
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Gemcitabine
Cisplatin
Brachytherapy
Brachytherapy, 30-35 Gy over 1 week
Pelvic radiation
Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* tumor that can be measured
* no previous treatment with chemotherapy or radiation for this cancer
* Karnofsky Performance Status Score \>=70
* able to give written consent
* willing and able to participate in the study, both during the active treatment and the follow-up period.
Exclusion Criteria
* damage to nerves such as being unable to distinguish hot and cold to touch
* used other experimental medication in past 30 days
* lab test results are not within the limits required for this study
* pregnancy or breast-feeding or possibility of becoming pregnant during this study and not using an approved method of birth control.
18 Years
70 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buenos Aires, , Argentina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sarajevo, , Bosnia and Herzegovina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mumbai, , India
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mexico City, , Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Karachi, , Pakistan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lima, , Peru
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bangkok, , Thailand
Countries
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References
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Duenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28.
Other Identifiers
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B9E-MC-JHQS
Identifier Type: -
Identifier Source: secondary_id
4015
Identifier Type: -
Identifier Source: org_study_id
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