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PHASE III INTERGROUP TRIAL OF SURGERY FOLLOWED BY (1) RADIOTHERAPY VS. (2) RADIOCHEMOTHERAPY FOR RESECTABLE HIGH RISK SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

PHASE III INTERGROUP TRIAL OF SURGERY FOLLOWED BY (1) RADIOTHERAPY VS. (2) RADIOCHEMOTHERAPY FOR RESECTABLE HIGH RISK SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK


OBJECTIVES: I. Evaluate locoregional control rates, patterns of first failure, and overall
and disease-free survival in patients with advanced squamous cell carcinoma of the head and
neck at high risk of locoregional recurrence who are treated postoperatively with concurrent
cisplatin and radiotherapy. II. Compare the toxicity of concurrent chemoradiotherapy vs.
radiotherapy alone in the postoperative setting.

OUTLINE: Randomized study. Arm I: Radiotherapy. Involved-field irradiation using Co60, 1-6
MV photons, or electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation
as in Arm I; plus Cisplatin, CDDP, NSC-119875.

PROJECTED ACCRUAL: 438 patients will be entered over approximately 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Biopsy-proven squamous cell carcinoma of one of the following
sites: Hypopharynx Larynx Oral cavity Oropharynx At least 1 of the following high-risk
factors required: Histologic extracapsular nodal extension Histologic involvement of 2 or
more regional lymph nodes Microscopically positive mucosal margins Complete resection of
all visible and palpable disease Therapy must begin within 8 weeks of tumor-related
surgery Bilateral resections may or may not be performed simultaneously Eligibility window
begins with first definitive surgery Neck dissection not required for T4 N0, truly midline
supraglottic tumors No tumors of the lip, nasopharynx, or sinuses No synchronous or
concurrent head and neck tumors No evidence of distant metastasis Concurrent registration
on Fixed Tumor Repository Study allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100%
Hematopoietic: WBC at least 3,500 Platelets at least 100,000 Hepatic: Not specified Renal:
Creatinine clearance greater than 50 mL/min Other: No medical contraindication to protocol
therapy No second malignancy within 5 years No pregnant or nursing women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head
and neck region Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jay S. Cooper, MD, FACR, FACRO

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000064279

NCT ID:

NCT00002670

Start Date:

September 1995

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage II squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage II squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Ireland Cancer CenterCleveland, Ohio  44106-5065
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Medical College of WisconsinMilwaukee, Wisconsin  53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
CCOP - Sooner StateTulsa, Oklahoma  74136