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A Randomized Phase III Trial Comparing Sequential Therapy With TPF/ Chemoradiation (ST) to Cisplatinum-Based Chemoradiotherapy With Accelerated Concomitant Boost Radiotherapy (CRT) For Locally Advanced Squamous Cell Cancer of the Head and Neck ("The Paradigm Study")


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

Thank you

Trial Information

A Randomized Phase III Trial Comparing Sequential Therapy With TPF/ Chemoradiation (ST) to Cisplatinum-Based Chemoradiotherapy With Accelerated Concomitant Boost Radiotherapy (CRT) For Locally Advanced Squamous Cell Cancer of the Head and Neck ("The Paradigm Study")

Inclusion Criteria


DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

Stage III or IV* disease

One of the following primary tumor sites:

Oral cavity

No mandible invasion Oropharynx Hypopharynx Larynx

The following primary tumor sites are excluded:

Nasal cavity Paranasal cavity Nasopharynx NOTE: *No evidence of distant metastases by
chest x-ray, abdominal ultrasound, or CT scan (for patients with liver function test
abnormalities) or bone scan (for patients with local symptoms) At least 1 uni- or
bi-dimensionally measurable lesion

PATIENT CHARACTERISTICS:

Age

Over 18 Performance status

WHO 0-1 Life expectancy

Not specified Hematopoietic

Neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 10 g/dL Hepatic

Bilirubin normal AST or ALT within eligibility range Alkaline phosphatase within
eligibility range Renal

Creatinine clearance > 60 mL/min Cardiovascular

No unstable cardiac disease despite treatment No myocardial infarction within the past 6
months Pulmonary

No chronic obstructive pulmonary disease, defined as requiring hospitalization for
pneumonia or respiratory decompensation within the past year

Obstruction caused by the tumor allowed Neurologic

No symptomatic peripheral neuropathy > grade 2 No symptomatic altered hearing > grade 2 No
history of significant neurologic or psychiatric disorders, including dementia or seizures
Other

No active drug addiction, including alcohol, cocaine, or intravenous drugs within the past
6 months No other malignancy within the past 5 years except adequately treated carcinoma
in situ of the cervix, basal cell or squamous cell skin cancer, or other cancer curatively
treated by surgery alone No active, clinically significant, uncontrolled infection No
autoimmune disease requiring therapy No unhealed or clinically active peptic ulcer disease
No hypercalcemia No other serious illness or medical condition No involuntary weight loss
> 25% of body weight within the past 2 months HIV negative Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception during and for
at least 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified Chemotherapy

No prior chemotherapy Endocrine therapy

Not specified Radiotherapy

No prior radiotherapy Surgery

No prior organ transplantation No prior surgery for this cancer

Biopsy allowed Other

More than 30 days since prior participation in another investigational study No other
concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival at 3 years

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Robert I. Haddad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Dana-Farber/Harvard Cancer Center

Study ID:

0120070101

NCT ID:

NCT00705068

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Medicine and Dentistry of New JerseyNewark, New Jersey  07103-2425