Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00262821|
Recruitment Status : Terminated (Study drug no longer available resulting in lack of study drug for participants.)
First Posted : December 7, 2005
Results First Posted : July 2, 2017
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cervical Adenocarcinoma Cervical Adenosquamous Cell Carcinoma Cervical Squamous Cell Carcinoma Stage IB Cervical Cancer Stage IIA Cervical Cancer Stage IIB Cervical Cancer Stage III Cervical Cancer Stage IVA Cervical Cancer||Drug: cisplatin Drug: tirapazamine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||402 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIIB and IVA Cervical Carcinoma Limited to the Pelvis|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Active Comparator: Arm I (cisplatin)
Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).
Experimental: Arm II (cisplatin, tirapazamine)
Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29 and cisplatin IV over 1 hour on days 1, 15, and 29.
- Progression-free Survival - Percentage of Patients Alive and Progression Free [ Time Frame: From study entry until first disease progression, death or date of last contact, up to 6 years ]Patients' progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact.
- Overall Survival [ Time Frame: From study entry to death or last contact, up to 6 years ]The observed length of life from entry into the study to death or date of last contact.
- Adverse Events (Grade 3 or Higher) During Treatment Period [ Time Frame: All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported ]Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262821
|Principal Investigator:||Paul DiSilvestro||Gynecologic Oncology Group|