EORTC 26981 / NCIC CE.3 (Stupp trial)
The 2005 trial that set the treatment every glioblastoma patient still receives. Nothing has replaced it in twenty years.
573 patients. Median OS 14.6 vs 12.1 months; 2-year OS 27% vs 10%; 5-year OS 9.8% vs 1.9%. Companion analysis (Hegi) showed MGMT promoter methylation predicts benefit. NEJM 2005; 5-year update Lancet Oncology 2009.
Setting
Newly diagnosed glioblastoma: radiotherapy + concurrent and adjuvant temozolomide vs radiotherapy alone
Phase
Phase 3
Sponsor
EORTC / NCIC
Registry
Headline result
OS 14.6 vs 12.1 months, HR 0.63.
Reported
2005
Enrolled
573
Replication
The Stupp regimen has been the control arm of every glioblastoma trial since; the MGMT-methylated benefit was confirmed repeatedly.
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 14.6 vs 12.1 months with Radiotherapy + temozolomide compared with Radiotherapy alone; about 2.5 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 37 percent lower chance of the event at any given time (hazard ratio 0.63, likely range 0.52 to 0.75).
Overall survival at 5 yearssurvival endpoint
- 9.8 vs 1.9 out of 100 alive at 5 years with Radiotherapy + temozolomide compared with Radiotherapy alone; 7.9 more per 100.
- Roughly one extra person helped for every 13 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Be careful
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Newly diagnosed glioblastoma: radiotherapy + concurrent and adjuvant temozolomide vs radiotherapy alone. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
573 participants enrolled.
Overall survivalprimary
HR 0.63 (0.52–0.75) · p <0.001
Radiotherapy + temozolomide
14.6 mo
Radiotherapy alone
12.1 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Radiotherapy + temozolomide | 287 | 14.6 months | 0.63 (0.52–0.75) | <0.001 | link |
| Radiotherapy alone | 286 | 12.1 months | ||||
| Overall survival at 5 years | Radiotherapy + temozolomide | — | 9.8% | — | — | link |
| Radiotherapy alone | — | 1.9% |
Replication
The Stupp regimen has been the control arm of every glioblastoma trial since; the MGMT-methylated benefit was confirmed repeatedly.