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Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the oropharynx, recurrent metastatic squamous neck cancer with occult primary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the mucosa, recurrent (primary and/or nodal), or a second primary (positive or negative nodal), of one of the following: Oral cavity Oropharynx Hypopharynx Larynx Paranasal sinus Neck disease of unknown origin No distant metastases No primary in the nasopharynx Must have complete gross resection of disease Must have positive final margins, soft tissue extension of primary, positive extracapsular extension of lymph node disease, or at least 4 positive nodes without extracapsular extension Reirradiation field must overlap the previous field for a minimum of 3 cm in height, width, and length At least 6 months since prior radiotherapy with an overlap volume of at least 45 Gy No grade 3 or 4 toxicity for the following organ tissues: RTOG grade 3 or 4 skin, subcutaneous tissue, larynx, joint, or RTOG grade 4 mucous membrane or bone from prior radiotherapy Radiotherapy must begin within 6-12 weeks of surgery Prior radiotherapy records must be available PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant No history of invasive malignancy that would be expected to cause death within 3 years PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • Veterans Affairs Medical Center - Tampa (Haley)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 28, 2000
Last Updated
December 3, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004226
Brief Title
Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy
Official Title
Phase I/II Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
July 2004
Overall Recruitment Status
Unknown status
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy following surgery in treating patients who have recurrent or second primary cancer of the head and neck following previous radiation therapy.
Detailed Description
OBJECTIVES: Determine the survival and local control in previously irradiated patients at high risk for local failure following regional resection of recurrent or second primary head and neck cancer. Determine the acute and late toxicities of this treatment in these patients. Determine the pattern of disease failure in these patients on this treatment. Determine any change in quality of life in these patients on this treatment. OUTLINE: Patients receive fractionated doses of radiotherapy five times weekly for 6 weeks. Quality of life is assessed prior to study, 2 months after radiotherapy, every 3 months for remainder of year 1, every 4 months for years 2-3, every 6 months for years 4-5, and then annually thereafter. Patients are followed 2 months after radiotherapy, every 3 months for year 1, every 4 months for year 2, every 6 months for years 3-5, and then annually thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the oropharynx, recurrent metastatic squamous neck cancer with occult primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the mucosa, recurrent (primary and/or nodal), or a second primary (positive or negative nodal), of one of the following: Oral cavity Oropharynx Hypopharynx Larynx Paranasal sinus Neck disease of unknown origin No distant metastases No primary in the nasopharynx Must have complete gross resection of disease Must have positive final margins, soft tissue extension of primary, positive extracapsular extension of lymph node disease, or at least 4 positive nodes without extracapsular extension Reirradiation field must overlap the previous field for a minimum of 3 cm in height, width, and length At least 6 months since prior radiotherapy with an overlap volume of at least 45 Gy No grade 3 or 4 toxicity for the following organ tissues: RTOG grade 3 or 4 skin, subcutaneous tissue, larynx, joint, or RTOG grade 4 mucous membrane or bone from prior radiotherapy Radiotherapy must begin within 6-12 weeks of surgery Prior radiotherapy records must be available PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant No history of invasive malignancy that would be expected to cause death within 3 years PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James L. Pearlman, MD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Veterans Affairs Medical Center - Tampa (Haley)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy

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