Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00047008
First received: October 3, 2002
Last updated: July 28, 2014
Last verified: May 2014
Results First Received: July 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Drug: cisplatin
Radiation: Standard fractionation RT
Radiation: Accelerated fractionation radiation therapy
Procedure: Conventional surgery for select patients

  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
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Reporting Groups
  Description
Standard Fractionation RT + Cisplatin Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
Accelerated Fractionation RT + Cisplatin Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.

Participant Flow:   Overall Study
    Standard Fractionation RT + Cisplatin     Accelerated Fractionation RT + Cisplatin  
STARTED     372     371  
COMPLETED     361     360  
NOT COMPLETED     11     11  
Withdrawn consent                 2                 3  
Ineligible                 9                 8  



  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 who did not withdraw consent.

Reporting Groups
  Description
Standard Fractionation RT + Cisplatin Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
Accelerated Fractionation RT + Cisplatin Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
Total Total of all reporting groups

Baseline Measures
    Standard Fractionation RT + Cisplatin     Accelerated Fractionation RT + Cisplatin     Total  
Number of Participants  
[units: participants]
  361     360     721  
Age  
[units: years]
Median ( Full Range )
  56  
  ( 34 to 82 )  
  55  
  ( 26 to 82 )  
  56  
  ( 26 to 82 )  
Gender  
[units: participants]
     
Female     52     72     124  
Male     309     288     597  



  Outcome Measures

1.  Primary:   Overall Survival (3-year Rate)   [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after 309 deaths have been reported. ]

2.  Secondary:   Local-regional Control   [ Time Frame: From randomization to date of failure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Disease-free Survival   [ Time Frame: From randomization to date of failure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Rate of Grade 3-5 Toxicity   [ Time Frame: From start of treatment to last follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Quality of Life   [ Time Frame: From randomization to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes   [ Time Frame: From randomization to date of death or last follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Correlation of COX-2 With Outcomes   [ Time Frame: From randomization to date of death or last follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  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
Organization: NRG Oncology
e-mail: SeiferheldW@nrgoncology.org


Publications of Results:
Wuthrick EJ, Zhang Q, Machtay M, et al.: The influence of institutional head and neck cancer (HNC) clinical trial accrual on overall survival (OS): An analysis of RTOG 0129. [Abstract] J Clin Oncol 30 (Suppl 15): A-5530, 2012.
Ang K, Zhang Q, Wheeler RH, et al.: A phase III trial (RTOG 0129) of two radiation-cisplatin regimens for head and neck carcinomas (HNC): impact of radiation and cisplatin intensity on outcome. [Abstract] J Clin Oncol 28 (Suppl 15): A-5507, 2010.
Gillison ML, Harris J, Westra W, et al.: Survival outcomes by tumor human papillomavirus (HPV) status in stage III-IV oropharyngeal cancer (OPC) in RTOG 0129. [Abstract] J Clin Oncol 27 (Suppl 15): A-6003, 2009.
Ang K, Pajak T, Rosenthal DI, et al.: A phase III trial to compare standard versus accelerated fractionation in combination with concurrent cisplatin for head and neck carcinomas (RTOG 0129): report of compliance and toxicity. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-21, S12-13, 2007.

Other Publications:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00047008     History of Changes
Other Study ID Numbers: RTOG 0129, CDR0000257233, RTOG-H-0129, RTOG-DEV-1069
Study First Received: October 3, 2002
Results First Received: July 28, 2014
Last Updated: July 28, 2014
Health Authority: United States: Federal Government