|
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 |