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Induction Chemotherapy Followed By Cetuximab and Radiation in HPV-Associated Resectable Stage III/IV Oropharynx Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT01084083
First received: March 9, 2010
Last updated: September 22, 2015
Last verified: September 2015
Results First Received: August 17, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Head and Neck Cancer
Precancerous Condition
Interventions: Biological: cetuximab
Radiation: intensity-modulated radiation therapy (IMRT)
Drug: Paclitaxel
Drug: Cisplatin

  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
The study was activated on March 17, 2010 and closed to accrual on October 19, 2011, with an accrual of 90 patients from 16 ECOG-affiliated institutions.

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
Overall Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.

Participant Flow:   Overall Study
    Overall  
STARTED     90  
Treated     89 [1]
Eligible     81  
Eligible and Treated     80 [2]
CR to Induction Therapy     56  
CR and Treated With 5400 cGy IMRT     44 [3]
COMPLETED     78  
NOT COMPLETED     12  
Adverse Event                 5  
Death                 1  
Withdrawal by Subject                 2  
Complicating disease                 1  
Unknown                 2  
Never started assigned therapy                 1  
[1] This is the all treated patients for toxicity analysis
[2] This is the eligible and treated patients for secondary efficacy endpoints
[3] This is the primary study population for the primary endpoint (24-month PFS).



  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 treated patients

Reporting Groups
  Description
Eligible and Treated Patients Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.

Baseline Measures
    Eligible and Treated Patients  
Number of Participants  
[units: participants]
  80  
Age  
[units: Years]
Median (Full Range)
  57  
  (35 to 73)  
Gender  
[units: participants]
 
Female     4  
Male     76  
Region of Enrollment  
[units: participants]
 
United States     80  



  Outcome Measures
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1.  Primary:   24-month Progression-free Survival   [ Time Frame: assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry ]

2.  Secondary:   24-months Overall Survival   [ Time Frame: assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry ]

3.  Secondary:   Primary Clinical Response Rate   [ Time Frame: assessed within 14 days after delivery of the third cycle of induction therapy ]


  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 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: ECOG-ACRIN statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-3012


Publications of Results:
Marur S, Lee JW, Cmelak A, et al.: ECOG 1308: A phase II trial of induction chemotherapy followed by cetuximab with low dose versus standard dose IMRT in patients with HPV-associated resectable squamous cell carcinoma of the oropharynx (OP). [Abstract] J Clin Oncol 30 (Suppl 15): A-5566, 2012.

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

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01084083     History of Changes
Other Study ID Numbers: CDR0000665170
ECOG-E1308 ( Other Identifier: Eastern Cooperative Oncology Group )
U10CA023318 ( US NIH Grant/Contract Award Number )
Study First Received: March 9, 2010
Results First Received: August 17, 2015
Last Updated: September 22, 2015
Health Authority: United States: Federal Government