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Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003627
  Purpose

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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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:

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: Fluorouracil Cisplatin
U.S. FDA Resources

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

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

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 to 70

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Greater than 3 months

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine no greater than 1.25 times ULN

Cardiovascular:

  • No severe cardiac disease

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy
  • No concurrent antineoplastic therapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • No prior surgery (except biopsy or adenectomy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003627

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Bensadoun RJ, Benezery K, Dassonville O, Magne N, Poissonnet G, Ramaioli A, Lemanski C, Bourdin S, Tortochaux J, Peyrade F, Marcy PY, Chamorey E, Vallicioni J, Seng H, Alzieu C, Gery B, Chauvel P, Schneider M, Santini J, Demard F, Calais G. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: Results at 2 years (FNCLCC-GORTEC). Int J Radiat Oncol Biol Phys. 2006 Mar 15;64(4):983-94. Epub 2006 Jan 10.

Study ID Numbers: CDR0000066710, FRE-FNCLCC-96003, EU-98027
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003627     History of Changes
Health Authority: United States: Federal Government

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:
Antimetabolites
Antimetabolites, Antineoplastic
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Pharyngeal Neoplasms
Immunosuppressive Agents
Pharyngeal Diseases
 Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Head and Neck Neoplasms
Fluorouracil
Therapeutic Uses
Stomatognathic Diseases
Oropharyngeal Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009



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