Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002476
First received: November 1, 1999
Last updated: August 1, 2013
Last verified: March 2010
  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. It is not yet known if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with advanced head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients with advanced head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Biological: bleomycin sulfate
Drug: fluorouracil
Drug: leucovorin calcium
Drug: methotrexate
Drug: vincristine sulfate
Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Radiotherapy Alone vs With Concurrent Chemotherapy With MTX or VBMF (VCR/BLEO/MTX/5-FU) vs Subsequent Chemotherapy vs Concurrent and Subsequent Chemotherapy in Patients With Advanced Head and Neck Cancer

Resource links provided by NLM:


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

Study Start Date: January 1990
Study Completion Date: January 2010
Detailed Description:

OBJECTIVES: I. Determine whether the addition of methotrexate (MTX) or VBMF (vincristine/bleomycin/methotrexate/fluorouracil) to radiotherapy for advanced carcinoma of the head and neck (with or without primary surgery) influences locoregional control and prolongs survival. II. Determine whether an effect on locoregional control or survival is apparent when chemotherapy is given during or following radiotherapy and whether it is increased when chemotherapy is given at both times. III. Determine, in a special randomization of patients with cancer of the oral cavity or oropharynx, whether neck irradiation improves locoregional control and survival.

OUTLINE: Randomized study. Patients without prior surgery are randomized 1:2 to Arms I:II-IV, while those with prior surgery are randomized 1:1 between Arms I and II only. Patients with tumors of the oral cavity or oropharynx may elect additional randomization between Arms V and VI and will receive irradiation of the primary according to the Manchester regimen. Arm I: Radiotherapy. Irradiation of the primary and/or lymph nodes according to 1 of 2 regimens (Manchester 3-week schedule or SECOG 6-week schedule) using megavoltage equipment. Arm II: Radiotherapy plus Concurrent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue. Involved-field irradiation as in Arm I; plus Methotrexate, MTX, NSC-740; with Leucovorin calcium, CF, NSC-3590; or VBMF: Vincristine, VCR, NSC-67574; Bleomycin, BLEO, NSC-125066; MTX; Fluorouracil, 5-FU, NSC-19893; with CF. Arm III: Radiotherapy plus Subsequent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue. Involved-field irradiation as in Arm I; plus MTX or VBMF; with CF. Arm IV: Radiotherapy plus Concurrent and Subsequent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue. Involved-field irradiation as in Arm I; plus MTX or VBMF; with CF. Arm V: Radiotherapy. Neck node irradiation using megavoltage equipment. Arm VI: Observation. No nodal irradiation.

PROJECTED ACCRUAL: At least 1,000 patients will be entered.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell cancer of the head and neck suitable for treatment with radiotherapy T2, T3, or T4 primary lesions Any N No distant metastasis May also be anaplastic carcinoma, verrucous carcinoma, or transitional cell carcinoma (as of 1/97) No occult primaries (as of 1/97) No adenocarcinomas, lymphomas, or melanomas (as of 1/97) Synchronous head and neck tumors are eligible (tumor with the worse prognosis is entered into study) (as of 1/97) Patients receiving surgery to neck nodes only must be randomized as surgery patients (as of 1/97) Patients with tumors of the oral cavity or oropharynx may additionally elect randomization to nodal irradiation vs. no further therapy provided there is no second primary

PATIENT CHARACTERISTICS: Age: 75 and under for patients electing participation in the nodal vs. no nodal irradiation portion of the study Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fit for any protocol treatment option Willing to receive any protocol treatment option Prior malignancy allowed provided the treating clinician considers the patient cured

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior therapy Endocrine therapy: No prior therapy Radiotherapy: No prior therapy Surgery: Prior biopsy or excision allowed

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002476

Locations
India
Raj Tilak
Indore, India, 452001
United Kingdom
Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, W1N 8AA
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Southend General Hospital
Westcliff-On-Sea, England, United Kingdom
Royal Victoria Hospital
Belfast, Northern Ireland, United Kingdom, BT12 6BJ
Belfast City Hospital Trust
Belfast, Northern Ireland, United Kingdom, BT8 8JR
Sponsors and Collaborators
Cancer Research UK
Investigators
Study Chair: Jeffrey S. Tobias, MD University College London Hospitals
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002476     History of Changes
Other Study ID Numbers: CRC-PHASE-III-91001, CDR0000076951, UKHAN-1
Study First Received: November 1, 1999
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II squamous cell carcinoma of the lip and oral cavity
stage II verrucous carcinoma of the oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV verrucous carcinoma of the oral cavity
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Methotrexate
Fluorouracil
Vincristine
Bleomycin
Levoleucovorin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antidotes

ClinicalTrials.gov processed this record on October 01, 2014