HD10
HD10 for Early Stages
Phase 3N = 1,370NCT00265018
- Population
- Newly diagnosed stage I or II Hodgkin's lymphoma with a favourable prognosis (GHSG definition).
- Design
- Multicentre randomised trial with four treatment groups: four cycles of ABVD then 30 Gy involved-field radiation therapy (group 1), four cycles of ABVD then 20 Gy (group 2), two cycles of ABVD then 30 Gy (group 3), or two cycles of ABVD then 20 Gy (group 4). The abstract reports the chemotherapy comparison (four versus two cycles, pooled over radiation dose) and the radiation-dose comparison (30 versus 20 Gy, pooled over chemotherapy) separately; it gives 5-year rates only for the chemotherapy comparison.
- Primary endpoint
- FFTF
- Arms
- 4 x ABVD + 30 Gy IFRT (group 1) (control): Four cycles of ABVD followed by 30 Gy involved-field radiation therapy
- 4 x ABVD + 20 Gy IFRT (group 2) (experimental): Four cycles of ABVD followed by 20 Gy involved-field radiation therapy
- 2 x ABVD + 30 Gy IFRT (group 3) (experimental): Two cycles of ABVD followed by 30 Gy involved-field radiation therapy
- 2 x ABVD + 20 Gy IFRT (group 4) (experimental): Two cycles of ABVD followed by 20 Gy involved-field radiation therapy
- Four cycles of ABVD (groups 1 and 2 pooled) (control): Four cycles of ABVD, either radiation dose (pooled analysis arm, not a randomised group)
- Two cycles of ABVD (groups 3 and 4 pooled) (experimental): Two cycles of ABVD, either radiation dose (pooled analysis arm, not a randomised group)
- People
- Engert A, senior author Diehl V, German Hodgkin Study Group
Δ 60-month FFTF−1.9 points
Show the numbers
| Endpoint | Analysis | 4 x ABVD + 20 Gy IFRT (group 2) / 2 x ABVD + 30 Gy IFRT (group 3) / 2 x ABVD + 20 Gy IFRT (group 4) / Two cycles of ABVD (groups 3 and 4 pooled) | 4 x ABVD + 30 Gy IFRT (group 1) / Four cycles of ABVD (groups 1 and 2 pooled) | Effect |
|---|---|---|---|---|
| FFTFRandomised patients grouped by number of ABVD cycles (four versus two; groups 1+2 versus 3+4); analysis population not labelled in the abstract | primaryEngert 2010 | 91.1% at 5 y (88.3–93.2%) | 93% at 5 y (90.5–94.8%) | P=0.39P value is for the difference in freedom from treatment failure between the two chemotherapy regimens. Overall survival did not differ between the chemotherapy regimens (P=0.61). Radiation dose comparison (20 Gy versus 30 Gy): freedom from treatment failure P=1.00, overall survival P=0.61; the abstract gives no 5-year rates for this comparison. Acute toxic effects and adverse events were most common in group 1. |
| Endpoint | Analysis | 4 x ABVD + 20 Gy IFRT (group 2) / 2 x ABVD + 30 Gy IFRT (group 3) / 2 x ABVD + 20 Gy IFRT (group 4) / Two cycles of ABVD (groups 3 and 4 pooled) | 4 x ABVD + 30 Gy IFRT (group 1) / Four cycles of ABVD (groups 1 and 2 pooled) | Effect |
|---|---|---|---|---|
| FFTFRandomised patients grouped by number of ABVD cycles (four versus two; groups 1+2 versus 3+4); analysis population not labelled in the abstract | primaryEngert 2010 | 91.1% at 5 y (88.3–93.2%) | 93% at 5 y (90.5–94.8%) | P=0.39P value is for the difference in freedom from treatment failure between the two chemotherapy regimens. Overall survival did not differ between the chemotherapy regimens (P=0.61). Radiation dose comparison (20 Gy versus 30 Gy): freedom from treatment failure P=1.00, overall survival P=0.61; the abstract gives no 5-year rates for this comparison. Acute toxic effects and adverse events were most common in group 1. |