Misonidazole and unconventional radiation in advanced squamous cell carcinoma of the esophagus: a phase II study of the Radiation Therapy Oncology Group
- Puerto Rico Cancer Center
This is a report on Radiation Therapy Oncology Group (RTOG) Protocol78-32, a Phase I/II prospective study aimed at determining tolerance, tumor response, and survival of squamous cell carcinoma of the esophagus treated with unorthodox fractionation radiotherapy combined with misonidazole. Misonidazole was administered by mouth 4 to 6 hr prior to radiation, at a dose of 1.0 to 1.25 Gm/.m/sup 2/; blood levels were measured at about 4 hr after intake of the drug and reported in micrograms/ml. Radiotherapy was administered at 4 to 6 hr post-misonidazole dose and given with 400 rad fractions, alternating 2 or 3 times/week, up to 4,800 rad. A total of 43 patients were entered; 26 are evaluated for survival at 1 year post accession. Thirty patients (88%) received the planned radiation course. Twenty-eight patients (78%) received the planned misonidazole dosage. Tumor response, evaluated in 18 patients, showed a complete regression (C.R.) in only 2 patients (11%); and partial response (P.R.) in 6 patients (33%). Eight patients (44%) showed no tumor response to planned therapy. Toxicity was acceptable and in 38 evaluated patients only 4 reported (11%) nausea and vomiting, 7 reported mild paresthesias (18%). The median survival was only five months. In 26 patients evaluated for 1 year survival determination, only 1 survived (3.8%) this period. In view of the poor tumor response and low survival observed, we do not recommend that this particular fractionation regimen with misonidazole be used in a Phase III randomized trial in squamous cell carcinoma of the esophagus.
- OSTI ID:
- 6707506
- Journal Information:
- Int. J. Radiat. Oncol., Biol. Phys.; (United States), Vol. 8:3/4
- Country of Publication:
- United States
- Language:
- English
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63 RADIATION, THERMAL, AND OTHER ENVIRON. POLLUTANT EFFECTS ON LIVING ORGS. AND BIOL. MAT.
MISONIDAZOLE
ORAL ADMINISTRATION
RADIOSENSITIVITY EFFECTS
SIDE EFFECTS
RADIOTHERAPY
CARCINOMAS
ESOPHAGUS
FRACTIONATED IRRADIATION
NAUSEA
NERVOUS SYSTEM DISEASES
PATIENTS
SURVIVAL TIME
VOMITING
ANTINEOPLASTIC DRUGS
AZOLES
BODY
DIGESTIVE SYSTEM
DISEASES
DRUGS
HETEROCYCLIC COMPOUNDS
IMIDAZOLES
IRRADIATION
MEDICINE
NEOPLASMS
NUCLEAR MEDICINE
ORGANIC COMPOUNDS
ORGANIC NITROGEN COMPOUNDS
ORGANS
RADIOLOGY
RADIOSENSITIZERS
SYMPTOMS
THERAPY
550603* - Medicine- External Radiation in Therapy- (1980-)
560151 - Radiation Effects on Animals- Man
560306 - Chemicals Metabolism & Toxicology- Man- (-1987)