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Trial record 1 of 1 for:    RTOG-9813
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Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004259
First Posted: January 27, 2003
Last Update Posted: November 13, 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.
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
Results First Submitted: May 25, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Brain and Central Nervous System Tumors
Interventions: Drug: BCNU 80mg/m2
Drug: TMZ 200mg/m2
Radiation: radiation therapy
Drug: CCNU
Drug: BCNU 150mg/m2
Drug: BCNU 200mg/m2
Drug: TMZ 150mg/m2 six 6-week cycles
Drug: TMZ 150mg/m2 six 8-week cycles

  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
No text entered.

Reporting Groups
  Description
Radiation Therapy + Temozolomide (TMZ) Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
RT + BCNU/CCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
Pilot Arm #1: RT+TMZ+BCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
Pilot Arm #2: RT+TMZ+BCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles

Participant Flow:   Overall Study
    Radiation Therapy + Temozolomide (TMZ)   RT + BCNU/CCNU   Pilot Arm #1: RT+TMZ+BCNU   Pilot Arm #2: RT+TMZ+BCNU
STARTED   98   103   15   14 
COMPLETED   97   99   15   14 
NOT COMPLETED   1   4   0   0 
Protocol Violation                1                2                0                0 
Withdrawal by Subject                0                2                0                0 



  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 patients

Reporting Groups
  Description
Radiation Therapy + Temozolomide (TMZ) Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
RT + BCNU/CCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
Pilot Arm #1: RT+TMZ+BCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
Pilot Arm #2: RT+TMZ+BCNU Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
Total Total of all reporting groups

Baseline Measures
   Radiation Therapy + Temozolomide (TMZ)   RT + BCNU/CCNU   Pilot Arm #1: RT+TMZ+BCNU   Pilot Arm #2: RT+TMZ+BCNU   Total 
Overall Participants Analyzed 
[Units: Participants]
 97   99   15   14   225 
Age 
[Units: Years]
Median (Full Range)
 42 
 (18 to 73) 
 43 
 (19 to 80) 
 48 
 (26 to 80) 
 41 
 (25 to 74) 
 43 
 (18 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      42  43.3%      47  47.5%      5  33.3%      6  42.9%      100  44.4% 
Male      55  56.7%      52  52.5%      10  66.7%      8  57.1%      125  55.6% 


  Outcome Measures
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1.  Primary:   (Phase III) Overall Survival (OS)   [ Time Frame: From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening. ]

2.  Primary:   (Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms   [ Time Frame: From start of treatment to 3 months ]

3.  Secondary:   (Phase III) Time to Tumor Progression (TTP)   [ Time Frame: From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening. ]

4.  Secondary:   (Phase III) Number of Patients With Grade 3 or Higher Toxicity   [ Time Frame: From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening. ]

5.  Secondary:   (Phase III) Correlation of Molecular Analyses With Overall Survival and Time to Tumor Progression   [ Time Frame: From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening. ]
Results not yet reported.   Anticipated Reporting Date:   09/2017  


  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
Accrual to the TMZ BCNU arm required an acceptable toxicity profile from a pilot arm. Treatment cessation/reduction for toxicity caused the combination arm to be dropped. Per the protocol, the pilot arms were not included in the Phase III analyses.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


Publications of Results:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00004259     History of Changes
Other Study ID Numbers: RTOG-9813
CDR0000067512
ECOG-R9813
NCCTG-RTOG-9813
First Submitted: January 28, 2000
First Posted: January 27, 2003
Results First Submitted: May 25, 2017
Results First Posted: November 13, 2017
Last Update Posted: November 13, 2017