ESTRO PT 2018

Phase III non-inferiority design with one interim analysis

Primary Objective:

The primary outcome is the rate of the progression-free survival (PFS) at 3 years, where PFS is defined as a local recurrence, regional recurrence, or death whichever occurs first.

Secondary Objectives: Secondary endpoints consist of both toxicity related outcomes and patient reported outcomes, among which: • PROs: MDASI, MDADI, FACT-HN, EQ5D • Phase II current endpoint (physician rated late G3 toxicity) • Feeding tube and weight loss after treatment • Cost effectiveness