Assessment All follow-up time points are taken from the date of completion of RT All follow-up time points are taken from the date of completion of RT All follow-up time points are taken from the date of completion of RT All follow-up time points are taken from the date of completion of RT All follow-up time points are taken from the date of completion of RT All follow-up time points are taken from the date of completion of RT
Baseline Adjuvant RT Adjuvant RT Adjuvant RT 3 - 12 months every 3 months after RT 13 - 60 months every 6 months after RT
Wk 1 Wk 2 Wk 3
Clinical Evaluation X
Eligibility Checklist X
Informed Consent X
Randomization X
RT QA Prior to center initiation and throughout the trial recruitment period Prior to center initiation and throughout the trial recruitment period Prior to center initiation and throughout the trial recruitment period Prior to center initiation and throughout the trial recruitment period Prior to center initiation and throughout the trial recruitment period Prior to center initiation and throughout the trial recruitment period
RT Treatment (Control Arm) X X X
RT Treatment (Test Arm) X
RT Verification (Control Arm) X X X
RT Verification (Test Arm) X
SAE X X X X X
Acute Toxicity X X X
FU Assessments X X X
EORTC QLQ C30 (Control Arm) X X At 6, 12 and 18 months after completion of RT At 6, 12 and 18 months after completion of RT
FACT-B (Control Arm) X X At 6, 12 and 18 months after completion of RT At 6, 12 and 18 months after completion of RT
EORTC QLQ C30 (Experimental Arm) X X At 6, 12 and 18 months after completion of RT At 6, 12 and 18 months after completion of RT
FACT-B (Experimental Arm) X X At 6, 12 and 18 months after completion of RT At 6, 12 and 18 months after completion of RT