A controlled clinical trial of misonidazole in the radiotherapy of patients with carcinoma of the bronchus
In 1977, during the initial development period of misonidazole, it was decided to start a double-blind randomized controlled clinical trial in carcinoma of bronchus, using a 6 fraction technique of radiotherapy. The patients included in the study were patients with squamous and large-cell undifferentiated carcinoma of the bronchus who were unsuitable for surgical resection, but where there was no evidence for metastases beyond the thorax. A total of 62 patients were randomized between January 1977 and September 1980. Tomography was performed at 2 monthly intervals and a particular effort was made to obtain post-mortem examinations. Fifty-four of the patients included have now died and post-mortems were obtained in 67%. Assessments of immediate tumor regression, tumor clearance, tumor regrowth and the findings at death were made. Thirty-three of the 62 patients were randomized to receive misonidazole and of these 12 (36%) showed peripheral neuropathy. No significant benefit was obtained with the use of misonidazole, as assessed by the parameters listed above. The full observation of those patients now dead showed that using a 6 fraction technique of radiotherapy, a complete tumor control was obtained in only 2. It was further found that the primary tumor was an important factor causing death in 85% of these patients. No evidence for distance metastases could be obtained in a considerable number of post-mortems. Among the possible reasons for the lack of benefit was the relatively low concentrations of sensitizer in the tumor, the advanced stage of disease and the 6 fraction technique of radiotherapy. The trial did, however, show that in a carefully selected group of patients the control of the primary tumor was important and that further efforts should be made to eradicate tumor.
- Research Organization:
- Mound Vernon Hospital, Northwood, England
- OSTI ID:
- 6724345
- Journal Information:
- Int. J. Radiat. Oncol., Biol. Phys.; (United States), Journal Name: Int. J. Radiat. Oncol., Biol. Phys.; (United States) Vol. 8:3/4; ISSN IOBPD
- Country of Publication:
- United States
- Language:
- English
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62 RADIOLOGY AND NUCLEAR MEDICINE
63 RADIATION, THERMAL, AND OTHER ENVIRON. POLLUTANT EFFECTS ON LIVING ORGS. AND BIOL. MAT.
ANTINEOPLASTIC DRUGS
AZOLES
BRONCHI
CARCINOMAS
DISEASES
DRUGS
EVALUATION
FRACTIONATED IRRADIATION
HETEROCYCLIC COMPOUNDS
IMIDAZOLES
IRRADIATION
MEDICINE
MISONIDAZOLE
NEOPLASMS
NERVOUS SYSTEM DISEASES
NUCLEAR MEDICINE
ORGANIC COMPOUNDS
ORGANIC NITROGEN COMPOUNDS
PATIENTS
RADIOLOGY
RADIOSENSITIVITY EFFECTS
RADIOSENSITIZERS
RADIOTHERAPY
RESPIRATORY SYSTEM
SIDE EFFECTS
THERAPY