RAPID
A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
Phase 3N = 602NCT00943423
- Population
- Newly diagnosed stage IA or IIA Hodgkin lymphoma; 602 patients recruited (median age 34 years), 571 had PET after three cycles of ABVD and 426 were PET-negative. The randomised comparison covers the 420 PET-negative patients who were randomly assigned.
- Design
- Patients with newly diagnosed stage IA or IIA Hodgkin lymphoma received three cycles of ABVD and then PET scanning. Patients with negative PET were randomly assigned to involved-field radiotherapy or no further treatment; patients with positive PET received a fourth cycle of ABVD and radiotherapy. Noninferiority design: the trial was designed to exclude a difference of 7 or more percentage points in the 3-year progression-free survival rate from an assumed 95% in the radiotherapy group.
- Primary endpoint
- PFS
- Arms
- Involved-field radiotherapy (control, n = 209): Three cycles of ABVD, negative PET, then involved-field radiotherapy
- No further therapy (experimental, n = 211): Three cycles of ABVD, negative PET, then no further treatment
- People
- Radford J, senior author Barrington S
Δ 36-month PFS−3.8 points
Show the numbers
| Endpoint | Analysis | No further therapy | Involved-field radiotherapy | Effect |
|---|---|---|---|---|
| PFSPET-negative patients randomly assigned after three cycles of ABVD (420); analysis population not labelled in the abstract | primarymedian follow-up 60 monthsRadford 2015 | 90.8% at 3 y (86.9–94.8%) | 94.6% at 3 y (91.5–97.7%) | Absolute risk difference -3.8 percentage points (95% CI -8.8 to 1.3) against a noninferiority margin of 7 percentage points; the abstract states that noninferiority of no further treatment was not shown. Progression events: 8 (radiotherapy group) and 20 (no further therapy group). Deaths: 8 (radiotherapy group; 3 with progression, 1 from Hodgkin lymphoma; 5 occurred in patients who did not receive radiotherapy) and 4 (no further therapy group; 2 with progression, none from Hodgkin lymphoma). |
| Endpoint | Analysis | No further therapy | Involved-field radiotherapy | Effect |
|---|---|---|---|---|
| PFSPET-negative patients randomly assigned after three cycles of ABVD (420); analysis population not labelled in the abstract | primarymedian follow-up 60 monthsRadford 2015 | 90.8% at 3 y (86.9–94.8%) | 94.6% at 3 y (91.5–97.7%) | Absolute risk difference -3.8 percentage points (95% CI -8.8 to 1.3) against a noninferiority margin of 7 percentage points; the abstract states that noninferiority of no further treatment was not shown. Progression events: 8 (radiotherapy group) and 20 (no further therapy group). Deaths: 8 (radiotherapy group; 3 with progression, 1 from Hodgkin lymphoma; 5 occurred in patients who did not receive radiotherapy) and 4 (no further therapy group; 2 with progression, none from Hodgkin lymphoma). |