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| Sponsor: | Cancer Research UK |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002476 |
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 III |
| Study Type: | Interventional |
| Study Design: | 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 |
| Study Start Date: | January 1990 |
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 |
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| India | |
| Raj Tilak | |
| Indore, India, 452001 | |
| United Kingdom, England | |
| Derriford Hospital | |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, W1N 8AA | |
| Royal Sussex County Hospital | |
| Brighton, England, United Kingdom, BN2 5BE | |
| Southend General Hospital | |
| Westcliff-On-Sea, England, United Kingdom | |
| United Kingdom, Northern Ireland | |
| Belfast City Hospital Trust | |
| Belfast, Northern Ireland, United Kingdom, BT8 8JR | |
| Royal Victoria Hospital | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BJ | |
| Study Chair: | Jeffrey S. Tobias, MD | University College London Hospitals |
More Information
| Study ID Numbers: | CDR0000076951, CRC-PHASE-III-91001, UKHAN-1 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002476 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
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Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leucovorin Reproductive Control Agents Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Vitamins Abortifacient Agents Methotrexate Micronutrients |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Vitamin B Complex Growth Substances Mitosis Modulators Vincristine Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Bleomycin Immunosuppressive Agents Pharmacologic Actions Neoplasms Fluorouracil |
