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Phase I/II Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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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 CenterBirmingham, Alabama  35294-3300
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354