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Optimized Intensity Modulated Irradiation for Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00580983
First received: December 25, 2007
Last updated: July 28, 2016
Last verified: July 2016
Results First Received: November 5, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Radiation: IMRT
Drug: Paclitaxel
Drug: Carboplatin
Drug: Cisplatin
Drug: 5-Fluorouracil

  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
90 participants were enrolled however only 80 started treatment. Only 73 participants completed treatment. 7 did not complete the 12 month post radiation therapy (RT)swallowing studies.

Reporting Groups
  Description
Chemo-IMRT

Chemotherapy:

Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.

Intensity-modulated Radiation Therapy (IMRT):

Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.

Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions.


Participant Flow:   Overall Study
    Chemo-IMRT
STARTED   80 
COMPLETED   73 
NOT COMPLETED   7 
Did not complete 12 mon post RT studies                7 



  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.
90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 participants were included in the baseline analysis.

Reporting Groups
  Description
Chemo-IMRT

Chemotherapy:

Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.

Intensity-modulated Radiation Therapy (IMRT):

Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.

Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions.


Baseline Measures
   Chemo-IMRT 
Overall Participants Analyzed 
[Units: Participants]
 73 
Age 
[Units: Years]
Median (Full Range)
 55 
 (50 to 78) 
Gender 
[Units: Participants]
 
Female   8 
Male   65 
Tumor Location 
[Units: Participants]
 
Tonsil   35 
Base of Tongue   38 
Gross Tumor Volume 
[Units: mL]
Median (Full Range)
 110 
 (19 to 378) 
T Stage [1] 
[Units: Participants]
 
Stage 1   9 
Stage 2   29 
Stage 3   17 
Stage 4   18 
[1] The TNM (Classification of Malignant Tumours) staging system is a standard system used to describe and summarize how far a patient's cancer has spread. The T indicates the size of the primary tumor. The numbers 0 through 4 indicate increasing severity.
N Stage [1] 
[Units: Participants]
 
Stage 0   6 
Stage 1   6 
Stage 2   55 
Stage 3   6 
[1] The TNM staging system is a standard system used to describe and summarize how far a patient's cancer has spread. The T describes the extent of spread to nearby lymph nodes. The numbers 0 through 4 indicate increasing severity.
AJCC Stage [1] 
[Units: Participants]
 
Stage III   9 
Stage IVA   58 
Stage IVB   6 
[1]

The AJCC staging system is a classification system developed by the American Joint Committee on Cancer (AJCC) for describing the extent of disease progression in cancer patients.

The TNM (Tumor, Lymph Node, Metastasis) classifications for cancers of the head and neck vary with location. Once the T, N, and M are determined, they are combined, and an overall stage of 0, I, II, III, IV is assigned.

Smoking Status 
[Units: Participants]
 
Never Smoked   26 
Previous Smoker   31 
Current Smoker   16 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Grade 0-1 Observer-rated Dysphagia   [ Time Frame: 12 months ]

2.  Secondary:   The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures   [ Time Frame: 5 years ]


  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
No modeling of observer-rated posttherapy dysphagia was performed because of the small number (four) of patients with greater than, or equal to, Grade 2 after 6 months.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Avraham Eisbruch, M.D.
Organization: University of Michigan Comprehensive Cancer Center
phone: 734-936-4302
e-mail: eisbruch@umich.edu



Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00580983     History of Changes
Other Study ID Numbers: UMCC 2-21
HUM 43020 Legacy 2002-513 ( Other Identifier: University of Michigan IRBMED )
Study First Received: December 25, 2007
Results First Received: November 5, 2014
Last Updated: July 28, 2016
Health Authority: United States: Institutional Review Board