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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompletedOver 18NCI, OtherDFCI 04-006
P30CA006516, CDR0000393548, AVENTIS-DFCI-04006, PARADIGM TRIAL, NCT00095875

Trial Description

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.

Further Study Information

OBJECTIVES:

Primary

  • Compare 3-year survival of patients with previously untreated stage III or IV squamous cell carcinoma of the head and neck treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by radiotherapy and carboplatin or docetaxel vs radiotherapy and cisplatin only.

Secondary

  • Compare 2-year progression-free status in patients treated with these regimens.
  • Compare 5-year survival of patients treated with these regimens.
  • Compare 3- and 5-year progression-free survival of patients treated with these regimens.
  • Compare the complete response rate in patients treated with these regimens.
  • Compare tumor site-specific survival in patients treated with these regimens.
  • Compare functional organ preservation in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Correlate tissue and germline markers with response, local/regional control, and the development of distant metastases in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
  • Arm II: Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.

Quality of life is assessed at baseline and then at 3, 12, and 24 months.

Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

National Cancer Institute

Robert I. HaddadStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00095875
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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