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Indian Journal of Cancer
Medknow Publications on behalf of Indian Cancer Society
ISSN: 0019-509X
EISSN: 1998-4774
Vol. 43, No. 4, 2006, pp. 151-155
Bioline Code: cn06024
Full paper language: English
Document type: Research Article
Document available free of charge

Indian Journal of Cancer, Vol. 43, No. 4, 2006, pp. 151-155

 en Safety and radiosensitizing efficacy of sanazole (AK 2123) in oropharyngeal cancers: Randomized controlled double blind clinical trial
Ullal SD, Shenoy KK, Pai MRSM, Chowta MN, Adiga SMN, Dinesh M, Kamath A, Kotian MS, Pai DK

Abstract

Oropharynx is an important site of cancer in India. Global comparison indicates higher incidences in India. Radiotherapy remains an important treatment modality. Efforts to improve loco-regional treatment and prolong survival are areas of focus. Radiosensitizers in hypoxic tumors have shown promise.
Aim: To study the safety and radiosensitizing efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage T2-4, N0-3, M0) as phase-II double blind controlled trial in patients treated with conventional radiotherapy.
SETTINGS AND DESIGN: Single institutional, randomized, double-blind, placebo-controlled trial.
MATERIALS AND METHODS: Group 1 (control; n =23) received normal saline infusion, group 2 (test; n =23) received sanazole biweekly 1.25 g intravenous infusion 15 minutes before radiotherapy. Surrogate end points of efficacy were tumor and nodal size; safety parameters were mucositis, salivary and skin reactions, dysphagia, vomiting, dysgeusia and neurological deficit. Investigators blinded to the trial evaluated patients, weekly during treatment for six weeks and thereafter monthly for three months.
STATISTICAL METHODS: Non-parametric, Friedman's, Chi square, Mann-Whitney U tests.
RESULTS: In the test, 15 (65%) patients had complete response, five (22%) partial/no response, two (9%) died, one (4%) lost to follow up. In the control, five (22%) patients had complete response, 16 (70%) partial/no response, one (4%) died, one (4%) lost to follow up. Short-term loco-regional response was better in the test ( DF = 3 , 95% Confidence Interval 0.418, 0.452, P=0.0048 ). In the test group significant vomiting and one case of grade 3 neurological deficit was observed.
CONCLUSION: The study validates the usefulness of sanazole for initial loco-regional control in oropharyngeal cancers.

Keywords
Radiosensitization, oropharyngeal cancer, sanazole

 
© Copyright 2006 Indian Journal of Cancer.
Alternative site location: http://www.indianjcancer.com/

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