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

NCT00002555 | Completed Phase 3

• 1 other identifier: EORTC-22931
• Study Type: interventional
• Target: 338
• Locations: 10 countries
• Sites: 19

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.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; 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; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx

Interventions

cisplatin DRUG

low-LET cobalt-60 gamma ray therapy RADIATION

low-LET electron therapy RADIATION

low-LET photon therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck of the following sites: Oral cavity Oropharynx Hypopharynx (only if ineligible for protocol EORTC-24891) Larynx T3-4, any N, M0 or any T, N2-3, M0 disease (UICC staging) resected with curative intent T3, N0 carcinoma of the larynx with suitable microscopically clear margins is ineligible At least one of the following high-risk characteristics required: Histopathologically positive surgical margins No gross residual disease Perineural involvement Extranodal spread of disease Oral cavity or oropharyngeal lesions with metastatic nodes at level 4 or 5 Vascular embolisms in the neck No metastases at diagnosis No known CNS disease 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (19)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, 21079, France

Location

CHR de Grenoble - La Tronche

Grenoble, 38043, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Hopital Jean Bernard

Poitiers, 86021, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milan, 20133, Italy

Location

Istituti Fisioterapici Ospitalieri - Roma

Rome, 00161, Italy

Location

University Medical Center Nijmegen

Nijmegen, NL-6252 HB, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Institute of Oncology, Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Ciudad Sanitaria Vall D'Hebron

Barcelona, 08035, Spain

Location

Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Universitaetsspital

Zurich, CH-8091, Switzerland

Location

Dokuz Eylul University School of Medicine

Izmir, 35340, Turkey (Türkiye)

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 16161069 RESULT

• 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.

  PMID: 15128894 RESULT

• 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.

  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.

  PMID: 9632290 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jacques Bernier, MD, PhD

  Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 26, 2004
• Study Start: February 1, 1994
• Primary Completion: October 1, 2000
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

BE (1); FR (6); IT (2); NL (1); TU (1); PL (1); ES (1); SL (1); GB (1); CH (4)