Head and Neck Cancer Clinical Trial
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
Verified date | March 2010 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | January 2010 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Raj Tilak | Indore | |
United Kingdom | Belfast City Hospital Trust | Belfast | Northern Ireland |
United Kingdom | Royal Victoria Hospital | Belfast | Northern Ireland |
United Kingdom | Royal Sussex County Hospital | Brighton | England |
United Kingdom | Middlesex Hospital- Meyerstein Institute | London | England |
United Kingdom | Derriford Hospital | Plymouth | England |
United Kingdom | Southend General Hospital | Westcliff-On-Sea | England |
Lead Sponsor | Collaborator |
---|---|
Cancer Research UK |
India, United Kingdom,
Tobias JS, Monson K, Gupta N, Macdougall H, Glaholm J, Hutchison I, Kadalayil L, Hackshaw A; UK Head and Neck Cancer Trialists' Group. Chemoradiotherapy for locally advanced head and neck cancer: 10-year follow-up of the UK Head and Neck (UKHAN1) trial. L — View Citation
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