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Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer

This study has been terminated.
(Study drug no longer available resulting in lack of study drug for participants.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00262821
First Posted: December 7, 2005
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: October 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: 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
Interventions: Drug: cisplatin
Drug: tirapazamine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible and evaluable patients.

Reporting Groups
  Description
Concurrent Cisplatin and Radiation Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Concurrent Cisplatin, Tirapazamine and Radiation Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium

Participant Flow:   Overall Study
    Concurrent Cisplatin and Radiation   Concurrent Cisplatin, Tirapazamine and Radiation
STARTED   198   204 
COMPLETED   194   185 
NOT COMPLETED   4   19 
Ineligible - wrong stage                0                3 
Ineligible - wrong cell type                2                2 
Ineligible - wrong primary                0                1 
Ineligible - inadequate pathology                1                3 
Ineligible - elevated creatinine                0                2 
Ineligible - required test not done                1                4 
Inevaluable - inadequate data                0                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible and evaluable patients.

Reporting Groups
  Description
Concurrent Cisplatin and Radiation Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Concurrent Cisplatin, Tirapazamine and Radiation Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Total Total of all reporting groups

Baseline Measures
   Concurrent Cisplatin and Radiation   Concurrent Cisplatin, Tirapazamine and Radiation   Total 
Overall Participants Analyzed 
[Units: Participants]
 194   185   379 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.9  (11.3)   48.4  (11.3)   48.7  (11.3) 
Age, Customized 
[Units: Participants]
     
20-30 years   7   10   17 
31-40 years   41   37   78 
41-50 years   65   61   126 
51-60 years   53   48   101 
61-70 years   20   23   43 
71-79 years   8   6   14 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      194 100.0%      185 100.0%      379 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      20  10.3%      24  13.0%      44  11.6% 
Not Hispanic or Latino      161  83.0%      138  74.6%      299  78.9% 
Unknown or Not Reported      13   6.7%      23  12.4%      36   9.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      8   4.1%      2   1.1%      10   2.6% 
Asian      6   3.1%      10   5.4%      16   4.2% 
Native Hawaiian or Other Pacific Islander      1   0.5%      2   1.1%      3   0.8% 
Black or African American      43  22.2%      30  16.2%      73  19.3% 
White      129  66.5%      134  72.4%      263  69.4% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      7   3.6%      7   3.8%      14   3.7% 
Gynecologic Oncology Group (GOG) Performance Status [1] 
[Units: Participants]
     
0 – fully active   147   141   288 
1 – restricted strenuous activity, ambulatory   46   41   87 
2 – ambulatory, difficulty walking   1   2   3 
3 – limited self-care, partly confined to bed   0   1   1 
4 – completely disabled, no self-care   0   0   0 
[1] 5-point, ordinal scale specifying patient's ability to perform activities
Tumor Grade [1] 
[Units: Participants]
     
1 – Well differentiated   8   12   20 
2 – Moderately differentiated   105   103   208 
3 – Poorly differentiated   78   67   145 
Not graded   3   3   6 
[1] Tumor grade was obtained from the central GOG Pathology Committee review
International Federation of Gynecologic and Obstetrics (FIGO), Clinical Staging, for Cervical Carcin [1] 
[Units: Participants]
     
IB   33   32   65 
IIA   11   12   23 
IIB   93   82   175 
IIIB   51   52   103 
IVA   6   7   13 
[1] International Federation of Gynecologic and Obstetrics (FIGO), Clinical Staging, for Cervical Carcinoma (1995). Stage IB is defined as clinical lesions confined to the cervix or pre-clinical lesions greater than stage 1A. Stage IIA is defined as the carcinoma extends beyond the cervix but has not extended on to the pelvic wall with no obvious parametrial involvement. Stage IIB has obvious parametrial involvement. Stage IIIB includes extension on to the pelvic wall and/or hydro-nephrosis or non-functioning kidney. Stage IVA is the spread of the growth to adjacent organs.
Histologic Type [1] 
[Units: Participants]
     
Squamous cell carcinoma   164   158   322 
Adenocarcinoma, unspecified   15   18   33 
Adenosquamous carcinoma   11   5   16 
Other   4   4   8 
[1] Histologic (cell) type was obtained from the central GOG Pathology Committee review
Para-aortic Lymph Node 
[Units: Participants]
     
Not sampled   25   33   58 
Sampled   169   152   321 
Brachytherapy 
[Units: Participants]
     
None   4   5   9 
Low-dose rate   52   51   103 
High-dose rate   138   129   267 
Cooperative Group Enrollment 
[Units: Participants]
     
Gynecologic Oncology Group (GOG)   167   167   334 
National Cancer Institute of Canada (NCIC)   24   17   41 
Other   3   1   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Overall Survival   [ Time Frame: From study entry to death or last contact, up to 6 years ]

3.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Premature closure due to lack of study drug leading to small number of subjects analyzed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
phone: 716-845-7733
e-mail: kurasa@nrgoncology.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262821     History of Changes
Obsolete Identifiers: NCT00704873
Other Study ID Numbers: NCI-2009-00591
NCI-2009-00591 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CAN-NCIC-GOG-0219
CDR0000455555
GOG-0219 ( Other Identifier: Gynecologic Oncology Group )
GOG-0219 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 6, 2005
First Posted: December 7, 2005
Results First Submitted: October 9, 2015
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017