Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NCI UAB-RAD-9601 UAB-F970430006, NCI-G99-1656, NCT00004226

Objectives

1. 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.
2. Determine the acute and late toxicities of this treatment in these patients.
3. Determine the pattern of disease failure in these patients on this treatment.
4. Determine any change in quality of life in these patients on this treatment.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics

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

Expected Enrollment

A total of 30 patients will be accrued for this study within 5 years.

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.

Trial Contact Information

Trial Lead Organizations

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

James Pearlman, MD, Protocol chair		Ph: 813-745-8424; 888-663-3488 Email: perlmjl@moffitt.usf.edu

Registry Information
Official Title		Phase I/II Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck
Trial Start Date		2000-05-19
Registered in ClinicalTrials.gov		NCT00004226
Date Submitted to PDQ		1999-12-09
Information Last Verified		2004-07-08
NCI Grant/Contract Number		P30-CA13148

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