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Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Radiation Toxicity

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Trial Information

Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer


OBJECTIVES:

- Assess target coverage and major salivary gland sparing in patients with stage II or
III oropharyngeal cancer treated with intensity-modulated radiotherapy.

- Determine the nature and prevalence of acute and late side effects of this treatment in
these patients.

- Determine the rate and pattern of locoregional tumor recurrence in these patients after
this treatment.

OUTLINE: This is a multicenter study.

Patients receive 3-D conformal radiotherapy and/or intensity-modulated radiotherapy daily 5
days a week for 6 weeks, in an effort to spare major salivary glands.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: Approximately 57-64 patients will be accrued for this study over 27
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven stage II or III (T1-T2, N0-N1) squamous cell carcinoma of the
oropharynx (tonsil, base of tongue, or palate)

- Lymph nodes in both sides of neck at risk of metastatic disease and require
radiotherapy

- Patients upstaged by imaging to N2 are eligible

- Measurable or evaluable disease

- Greater than 1 cm in one dimension or with necrotic regions if by CT or MRI scan

- Surgery of the primary tumor or lymph nodes limited to incisional or excisional
biopsies

- No distant metastases

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No active untreated infection

- No other malignancy within the past 5 years except nonmelanoma skin cancer or a
carcinoma not of head or neck origin

- No concurrent major medical or psychiatric illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- More than 3 months since prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior head or neck radiotherapy

Surgery:

- See Disease Characteristics

Other:

- No other concurrent treatment for head and neck cancer

- No prophylactic amifostine or pilocarpine

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Acute salivary gland toxicity

Safety Issue:

Yes

Principal Investigator

Avraham Eisbruch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068231

NCT ID:

NCT00006360

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Radiation Toxicity
  • stage II squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • radiation toxicity
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms
  • Radiation Injuries

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
CCOP - Kansas CityKansas City, Missouri  64131
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
All Saints Cancer Center at All Saints HealthcareRacine, Wisconsin  53405
Community Cancer Center at Rutland Regional Medical CenterRutland, Vermont  05701
Community Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755