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Chemotherapy and Radiation Therapy (RT) With or Without Vandetanib in Treating Patients With High-Risk Stage III or Stage IV Head and Neck Cancer

This study has been terminated.
(Withdrawal of drug supply.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00720083
First received: July 19, 2008
Last updated: July 3, 2013
Last verified: July 2013
Results First Received: March 22, 2013  
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
Drug: vandetanib
Radiation: radiation therapy

  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
34 subjects were registered, after which 2 did not continue to randomization due to physician preference.

Reporting Groups
  Description
RT + Cisplatin Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
RT + Cisplatin + Vandetanib Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    RT + Cisplatin     RT + Cisplatin + Vandetanib  
STARTED     17     15  
COMPLETED     16 [1]   13  
NOT COMPLETED     1     2  
Ineligible                 1                 2  
[1] Subjects with data for the primary analysis are considered to have completed the study.



  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.
All eligible patients.

Reporting Groups
  Description
RT + Cisplatin Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
RT + Cisplatin + Vandetanib Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    RT + Cisplatin     RT + Cisplatin + Vandetanib     Total  
Number of Participants  
[units: participants]
  16     13     29  
Age  
[units: years]
Median ( Full Range )
  57  
  ( 40 to 74 )  
  53  
  ( 39 to 76 )  
  57  
  ( 39 to 76 )  
Gender  
[units: participants]
     
Female     3     3     6  
Male     13     10     23  



  Outcome Measures

1.  Primary:   Disease-free Survival   [ Time Frame: From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been 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
This study terminated early with 34 subjects accrued out of 170 planned, therefore no analyses were performed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
e-mail: wseiferheld@acr.com


No publications provided


Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00720083     History of Changes
Other Study ID Numbers: RTOG-0619, CDR0000599867
Study First Received: July 19, 2008
Results First Received: March 22, 2013
Last Updated: July 3, 2013
Health Authority: United States: Food and Drug Administration