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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003627
• Other study ID #: CDR0000066710
• Secondary ID: FRE-FNCLCC-96003
• Status: Completed
• Phase: Phase 3
• Start date: October 1998
• Est. completion date: January 2011

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2011
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Cancer
• Oropharyngeal Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	CHU de la Timone	Marseille
France	Institut J. Paoli and I. Calmettes	Marseille
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Centre Antoine Lacassagne	Nice
France	Institut Jean Godinot	Reims
France	Centre Henri Becquerel	Rouen
France	Centre Rene Huguenin	Saint Cloud
France	Centre Hospitalier Universitaire Bretonneau de Tours	Tours
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (1)

Bensadoun RJ, Bénézery K, Dassonville O, Magné N, Poissonnet G, Ramaïoli A, Lemanski C, Bourdin S, Tortochaux J, Peyrade F, Marcy PY, Chamorey E, Vallicioni J, Seng H, Alzieu C, Géry B, Chauvel P, Schneider M, Santini J, Demard F, Calais G. French multice — View Citation