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Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: January 2001

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known whether radiation therapy with combination chemotherapy is more effective than radiation therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically removed.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin and fluorouracil with radiation therapy alone in treating patients who have advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed.

Condition Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Drug: fluorouracil
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Radiotherapy With or Without Cisplatin and Fluorouracil for Locally Advanced, Nonresectable Squamous Cell Cancer of the Oropharynx or Hypopharynx

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 160
Study Start Date: October 1998
Detailed Description:


  • Compare the overall survival and survival without relapse for 1, 3, and 5 years of patients with squamous cell cancer of the oropharynx or hypopharynx after treatment with twice a day radiotherapy with or without cisplatin and fluorouracil.
  • Compare the presence of distant metastases at 1, 3, and 5 years in these patients after these treatments.
  • Compare the local control and duration of control in these patients after these treatments.
  • Compare the clinical changes and histological changes at 6 months in these patients after these treatments.
  • Determine the rate of complete response in these patients after these treatments.
  • Determine the early and late toxic effects of these regimens in these patients.
  • Determine the quality of life of these patients.
  • Determine the pharmacokinetics of fluorouracil and tolerability of this regimen in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and primary site of disease (oropharynx vs hypopharynx)

Patients are randomized to one of two treatment arms.

  • Arm I: Patients undergo radiotherapy twice a day, 6 hours apart, 5 days a week, for 7 weeks.
  • Arm II: Patients undergo radiotherapy as in arm I, plus concurrent chemotherapy consisting of cisplatin IV on day 1 and fluorouracil by continuous infusion over 24 hours on days 1-5. Courses are repeated every 3 weeks for 3 courses.

Patients are followed every month for 1 year, every 2-3 months for 2 years, then every 6 months for at least 2 years.

PROJECTED ACCRUAL: A total of 160 patients (80/arm) will be accrued for this study within 4.5 years.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven squamous cell cancer of the oropharynx or hypopharynx

    • T4 and nonresectable OR
    • T3 extended to oropharynx or hypopharynx and nonresectable
    • N0-3 (stage III or IV)
  • No distant metastases



  • 18 to 70

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Greater than 3 months


  • Neutrophil count at least 2000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • Transaminases no greater than 2.5 times ULN


  • Creatinine no greater than 1.25 times ULN


  • No severe cardiac disease


  • No prior malignancy except basal cell skin cancer
  • No uncontrolled infection


Biologic therapy:

  • Not specified


  • No prior chemotherapy
  • No concurrent antineoplastic therapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy


  • No prior surgery (except biopsy or adenectomy)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003627

Centre Oscar Lambret
Lille, France, 59020
Institut J. Paoli and I. Calmettes
Marseille, France, 13273
CHU de la Timone
Marseille, France, 13385
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
Institut Jean Godinot
Reims, France, 51056
Centre Henri Becquerel
Rouen, France, 76038
Centre Rene Huguenin
Saint Cloud, France, 92211
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France, 37044
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
Study Chair: Rene-Jean Bensadoun, MD Centre Antoine Lacassagne
  More Information

Publications: Identifier: NCT00003627     History of Changes
Other Study ID Numbers: CDR0000066710
Study First Received: November 1, 1999
Last Updated: February 6, 2009

Keywords provided by National Cancer Institute (NCI):
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 26, 2017