Phase I/II Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Phase I/II Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
James L. Pearlman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Federal Government
Study ID:
CDR0000067467
NCT ID:
NCT00004226
Start Date:
May 2000
Completion Date:
Related Keywords:
- Head and Neck Cancer
- 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
- Head and Neck Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
