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Phase 3 N=145 Randomized Treatment

Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial)

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00095875 ↗
Enrolled (actual)
145
Serious AEs
58.6%
Results posted
Jul 2013
Primary outcome: Primary: Overall Survival — 73; 78 percent of patients

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
carboplatin (Drug); cisplatin (Drug); docetaxel (Drug); fluorouracil (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Dana-Farber Cancer Institute
Primary completion
Apr 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Survival		 73; 78 —
SECONDARY
Progression-free Survival and Disease-specific Survival as Assessed by Disease Progression or Death and Log Rank Tests at the Median, and 2, 3, and 5 Years		 67; 69 —

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy and radiation therapy is most effective in treating head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have stage III or stage IV head and neck cancer.

Eligibility Criteria

List of Inclusion Criteria:

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00095875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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