A phase I/II study of the hypoxic cell sensitizer misonidazole as an adjunct to high fractional dose radiotherapy in patients with unresectable squamous cell carcinoma of the head and neck: a RTOG randomized study (#79-04) | Canada Hyperbarics Skip to main content
RCT Int J Radiat Oncol Biol Phys 1989

A phase I/II study of the hypoxic cell sensitizer misonidazole as an adjunct to high fractional dose radiotherapy in patients with unresectable squamous cell carcinoma of the head and neck: a RTOG randomized study (#79-04)

Lee D, Pajak T, Stetz J, Order S, Weissberg J, Fischer J — Int J Radiat Oncol Biol Phys, 1989

Tier 1, Curated

Manually reviewed and included in the Canada Hyperbarics research database.

Summary

What Researchers Did

Researchers conducted a randomized trial to evaluate the safety and effectiveness of adding misonidazole, a hypoxic cell sensitizer, to high-dose radiation therapy for patients with advanced, unresectable squamous cell carcinoma of the head and neck.

What They Found

Out of 40 patients analyzed, 21 received radiation plus misonidazole. Misonidazole was associated with minor side effects in a few patients, such as persistent numbness (1 patient) and nausea (2 patients). The initial complete response rates were 53% for radiation alone and 48% for radiation plus misonidazole, while 2-year loco-regional control rates were 10% and 17% respectively, showing no significant improvement with misonidazole.

What This Means for Canadian Patients

This study suggests that adding misonidazole to high fractional dose radiotherapy does not significantly improve outcomes for patients with advanced, unresectable head and neck cancers. Canadian patients with similar conditions would therefore likely not be offered this specific drug combination as an effective treatment strategy.

Canadian Relevance

No direct Canadian connection identified.

Study Limitations

The study's findings are limited by its relatively small sample size of 40 patients and its age, having been conducted between 1979 and 1983.

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Study Details

Study Type RCT
Category Radiation Injury
Source Pubmed
PubMed ID 2646255
Year Published 1989
Journal Int J Radiat Oncol Biol Phys
MeSH Terms Aged; Carcinoma, Squamous Cell; Clinical Trials as Topic; Combined Modality Therapy; Female; Head and Neck Neoplasms; Humans; Male; Middle Aged; Misonidazole; Multicenter Studies as Topic; Prospective Studies; Radiotherapy; Radiotherapy Dosage; Random Allocation

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Disclaimer: This study summary is provided for informational and educational purposes only. It does not constitute medical advice. The information presented reflects the findings of the original research authors and may not represent the views of Canada Hyperbarics. Always consult a qualified healthcare professional before making treatment decisions.