Critical appraisal:Komarnicky LT, Phillips TL, Martz K, Asbell S, Isaacson S, Urtasun R 1991

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Critical Appraisal

Article being appraised

Komarnicky LT, Phillips TL, Martz K, Asbell S, Isaacson S, Urtasun R. A randomized phase III protocol for the evaluation of misonidazole combined with radiation in the treatment of patients with brain metastases (RTOG-7916). Int J Radiat Oncol Biol Phys 1991 Jan;20(1):53-8 Available from: http://www.ncbi.nlm.nih.gov/pubmed/1993631.


Applicable clinical question

Key Facts

Study Design

randomised controlled trial

Number of Patients:

859


Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
Low risk of bias Comments: Large RCT by RTOG. Standard protocols and modern techniques. Brain mets diagnosed on brain CT. However, method of randomisation not stated.Adequate frequency and length of FU.


Size of effect
1 Reason for decision: This was a 4 arm RCT randomising between 2 RT fractionations and misonidazole. There was no difference in survival or deterioration in performance status between the arms. Toxicity only reported for miso arms.
Relevance of evidence
1 Additional comments: Clinically relevant endpoint of survival and time to deterioration in performance status.
Result of appraisal

Jutta's tick icon.png Included




Completed by

Associate Professor Shalini Vinod MBBS MD FRANZCR


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Article
Komarnicky LT, Phillips TL, Martz K, Asbell S, Isaacson S, Urtasun R. A randomized phase III protocol for the evaluation of misonidazole combined with radiation in the treatment of patients with brain metastases (RTOG-7916). Int J Radiat Oncol Biol Phys 1991 Jan;20(1):53-8 Available from: http://www.ncbi.nlm.nih.gov/pubmed/1993631.
Assigned to
User:Shalini.vinod
Topic area
Guidelines:Lung cancer/Treatment/Non-small-cell stage IV inoperable
Clinical question
Form
Form:Critical appraisal


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