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Property:Outcome specification

From CAMIH

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Incidence of second primary tumors (SPT) from the day of randomization until the occurrence of the SPT/death/date of the last visit; median follow-up: 52 months  +
Local recurrence operationalized as possible indicator of compromisation of treatment (radiotherapy) efficacy; median duration of follow-up: 51 months  +
Acute Adverse Effects of Radiation Therapy: most severe radiation therapy adverse effect with regards to baseline status, graded from 0 (no symptom) to 4 (severe symptom), in six sites (skin, mucosa, ear, salivary glands, pharynx and esophagus, and larynx)  +
Separately for cause of death: any cause, initial cancer, second primary cancer, any cancer, noncancer causes Median follow-up: - intervention arm: 6.4 years - placebo arm: 6.6 years  +