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

NCT ID: NCT00003627

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-10-31
• Study Completion Date: 2011-01-31

Brief 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.

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rene-Jean Bensadoun, MD

Role: STUDY_CHAIR

Centre Antoine Lacassagne

Locations

Centre Oscar Lambret

Lille, , France

Institut J. Paoli and I. Calmettes

Marseille, , France

CHU de la Timone

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

Vandœuvre-lès-Nancy, , France

Countries

France

References

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. doi: 10.1016/j.ijrobp.2005.09.041. Epub 2006 Jan 10.

Reference Type: RESULT

PMID: 16376489 (View on PubMed)

Other Identifiers

FRE-FNCLCC-96003

Identifier Type: -

Identifier Source: secondary_id

EU-98027

Identifier Type: -

Identifier Source: secondary_id

CDR0000066710

Identifier Type: -

Identifier Source: org_study_id