High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer

NCT ID: NCT00002555

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-02-28

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. It is not yet known if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer.

Detailed Description

OBJECTIVES: I. Determine whether the addition of cisplatin to high-dose postoperative radiotherapy increases the disease-free survival rate of patients with locally advanced head and neck carcinomas at high risk of recurrence following radical surgery.

OUTLINE: Randomized study. Patients are registered and randomized to treatment within 25 days of surgery. Arm I: Radiotherapy. Irradiation of the preoperative primary tumor site with a boost to areas at high risk for recurrence using Co60 equipment, 4-6 MV linear accelerators, or 6-12 MeV electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation as in Arm I; plus Cisplatin, CDDP, NSC-119875.

PROJECTED ACCRUAL: A total of 338 evaluable patients will be studied.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

low-LET cobalt-60 gamma ray therapy

Intervention Type: RADIATION

low-LET electron therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Hematopoietic: WBC at least 4,000 Platelets at least 100,000 Hemoglobin normal (at least 6.8 mmoles/liter) Hepatic: Bilirubin no greater than 2 times normal Other liver function tests no greater than 2 times normal Renal: Creatinine no greater than 1.3 mg/dL (120 micromoles/liter) Creatinine clearance greater than 60 mL/min Other: No active, uncontrolled infection No requirement for antibiotics that might interfere with platinum excretion No requirement for drugs affecting bone marrow function (e.g., lithium, corticosteroids) No medical condition precluding postoperative chemotherapy No prior or concurrent malignancy other than nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior locoregional radiotherapy to the head and neck Surgery: Excision with curative intent required

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

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Bernier, MD, PhD

Role: STUDY_CHAIR

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Locations

Institut Jules Bordet

Brussels, , Belgium

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, , France

CHR de Grenoble - La Tronche

Grenoble, , France

Centre Oscar Lambret

Lille, , France

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, , France

Hopital Jean Bernard

Poitiers, , France

Institut Gustave Roussy

Villejuif, , France

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milan, , Italy

Istituti Fisioterapici Ospitalieri - Roma

Rome, , Italy

University Medical Center Nijmegen

Nijmegen, , Netherlands

Medical University of Gdansk

Gdansk, , Poland

Institute of Oncology, Ljubljana

Ljubljana, , Slovenia

Ciudad Sanitaria Vall D'Hebron

Barcelona, , Spain

Ospedale San Giovanni

Bellinzona, , Switzerland

Inselspital, Bern

Bern, , Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Universitaetsspital

Zurich, , Switzerland

Dokuz Eylul University School of Medicine

Izmir, , Turkey (Türkiye)

Nottingham City Hospital NHS Trust

Nottingham, England, United Kingdom

Countries

Belgium; France; Italy; Netherlands; Poland; Slovenia; Spain; Switzerland; Turkey (Türkiye); United Kingdom

References

Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, Ozsahin EM, Jacobs JR, Jassem J, Ang KK, Lefebvre JL. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck. 2005 Oct;27(10):843-50. doi: 10.1002/hed.20279.

Reference Type: RESULT

PMID: 16161069 (View on PubMed)

Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.

Reference Type: RESULT

PMID: 15128894 (View on PubMed)

Bernier J, Domenge C, Eschwege F, et al.: Chemo-radiotherapy, as compared to radiotherapy alone, significantly increases disease-free and overall survival in head and neck cancer patients after surgery: results of EORTC phase III trial 22931. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-1, 1, 2001.

Reference Type: RESULT

Valley JF, Bernier J, Tercier PA, Fogliata-Cozzi A, Rosset A, Garavaglia G, Mirimanoff RO. Quality assurance of the EORTC radiotherapy trial 22931 for head and neck carcinomas: the dummy run. Radiother Oncol. 1998 Apr;47(1):37-44. doi: 10.1016/s0167-8140(97)00218-1.

Reference Type: RESULT

PMID: 9632290 (View on PubMed)

Other Identifiers

EORTC-22931

Identifier Type: -

Identifier Source: secondary_id

EORTC-22931

Identifier Type: -

Identifier Source: org_study_id