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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:
ClinicalTrials.gov Identifier:
NCT00720083
First Posted: July 22, 2008
Last Update Posted: November 17, 2015
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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
Results First Submitted: March 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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



Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00720083     History of Changes
Other Study ID Numbers: RTOG-0619
CDR0000599867
First Submitted: July 19, 2008
First Posted: July 22, 2008
Results First Submitted: March 22, 2013
Results First Posted: May 8, 2013
Last Update Posted: November 17, 2015