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Intensity-Modulated Radiotherapy for Recurrent Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00257335
Recruitment Status : Withdrawn (Due to no patient enrollment this study was withdrawn/closed)
First Posted : November 22, 2005
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Nilam Ramsinghani, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE November 21, 2005
First Posted Date  ICMJE November 22, 2005
Last Update Posted Date July 31, 2017
Study Start Date  ICMJE October 14, 2004
Actual Primary Completion Date June 12, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
Identify acute and late toxicities and response rates
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2005)
Identify acute and late toxicities and esponse rates
Change History Complete list of historical versions of study NCT00257335 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intensity-Modulated Radiotherapy for Recurrent Head and Neck Cancer
Official Title  ICMJE A Phase II Protocol of Intensity-Modulated Radiotherapy for Treatment of Previously Irradiated Recurrent Head and Neck Cancer
Brief Summary

To demonstrate safety and efficacy of intensity-modulated radiotherapy (IMRT) for treatment of previously irradiated recurrent head and neck cancer.

Specific Aims: Identify acute and late toxicities, response rates, locoregional control, disease free survival, and overall survival with IMRT. Also, tumor response, the amount of tumor shrinkage or reduction, will be analyzed.

Rationale: Recurrent head and neck cancer is regarded as having limited treatment modalities since salvage surgery can only be accomplished on limited subgroups of patients. Chemotherapy has not shown clear clinical benefits and has significant toxicity. Re-irradiation has been used as a treatment modality. However, the re-irradiation dose is limited by significant toxicity that occurs with the cumulative dose of radiation. The use of IMRT can give a high dose to the recurrent tumor while limiting the dose to critical structures in the vicinity of the reirradiated volume thereby limiting toxicity and treating the recurrence to an adequate dose.

The number of subjects was determined from 2 stage design with a historical control group as comparison, and these numbers of subjects were found to be 40.

It is assumed that this treatment regimen will not be of further interest if the true response rate is less than 32.6% (Po0.326). It is also assumed that a true response rate of 53% or more (P10.53) would be of considerable interest in the treatment of recurrent head and neck cancer. The type I error (the probability of rejecting the hypothesis that the proportion responding to the treatment is less than or equal to Po when this hypothesis is actually true) is 0.05.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma of the Head and Neck
Intervention  ICMJE Procedure: IMRT
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 26, 2017)
0
Original Enrollment  ICMJE
 (submitted: November 21, 2005)
40
Actual Study Completion Date  ICMJE June 12, 2007
Actual Primary Completion Date June 12, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients must have pathologically confirmed recurrence (reappearance of previously cleared) of a squamous cell cancer primary located in the upper aerodigestive tract or a second squamous cell primary. Patients may have experienced more than one recurrence as long as the first recurrence occurred greater than 6 months following the end of the prior RT. Pathology slides from primary as well as recurrence must to be obtained for review by UCI Department of Pathology to confirm histology and patient eligibility. Previous radiation records including simulation and portal films must be submitted to the UCI Department of Radiation Oncology for review of treated areas and to assure that spinal cord tolerance is not exceeded.
  2. The recurrence or second primary must have defined bidimensional measurement as follows: All tumor measurements must be recorded in centimeters and should consist of the two longest perpendicular cross-diameters. Patients will be separately assessed for response by physical exam and by CT scan with contrast (unless contraindicated) or MRI scan with T1 contrast with gadolinium (unless contraindicated) and T2 sequences prior to and two months following completion of therapy. Both the clinical (physical exam) and radiographic (CT or MRI) response will be recorded on the study forms.
  3. Recurrence or second primary must be confined to the head and neck above the clavicle.
  4. The patient must not be a candidate for or refuses complete surgical (re)resection.
  5. The majority (>75%) of the tumor volume must have been in areas previously irradiated to >45 Gy. The previous irradiation must not exceed a maximum of 75 Gy.
  6. Primary and recurrent cancer treatment cumulative radiation dose must limit total spinal cord dose to 50 Gy.
  7. Patients must be at least 1 month from prior chemotherapy and radiation therapy.
  8. Karnofsky status 60 or greater. (appendix)
  9. WBC >4000/mm3, granulocytes >2,000/mm3, platelets >100,000/mm3, serum bilirubin <1.5 mg/dl, creatinine <1.8 mg/dl within one month from enrollment in protocol.
  10. If liver chemistries are above normal limits, a liver ultrasound or CT will be required.
  11. Patient must not have a history of other invasive malignancies within the past five years, excluding non-melanomatous skin cancer or cervical cancer in-situ.

Exclusion Criteria

  1. Distant metastases.
  2. History of other invasive malignancies within the past five years excluding non-melanomatous skin cancer or cervical cancer in-situ.
  3. Medical condition, which would impede patient tolerance of therapy, completion of therapy or limit survival.
  4. Women who are pregnant will be excluded from this trial. A pregnancy test will be offered to women of child bearing age who are otherwise eligible for the protocol.
  5. Patients under 18 years of age will be excluded since head and neck cancer is unlikely and due to risk of long term toxicity from radiation including secondary malignancy
  6. Patients on any treatment currently for the recurrent head and neck cancer
  7. Patients have any untreated infection
  8. Patients are candidate for complete surgical resection.
  9. Patients have the previous irradiation exceeded a maximum of 75 Gy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00257335
Other Study ID Numbers  ICMJE UCI 03-58
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nilam Ramsinghani, University of California, Irvine
Study Sponsor  ICMJE Nilam Ramsinghani
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nilam Ramshinghani, MD Chao Family Comprehensive Cancer Center
PRS Account University of California, Irvine
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP