Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma
Phase 3N = 240
- Population
- Measurable stage IV melanoma (240 patients randomised)
- Design
- Multicentre randomised phase 3 trial of the Dartmouth regimen versus dacarbazine alone, repeated every 3 weeks. The abstract states the aims as comparing overall survival, objective response and toxicity. No registry number appears in the abstract.
- Arms
- Dartmouth regimen (experimental): Dacarbazine 220 mg per square metre and cisplatin 25 mg per square metre days 1 to 3, carmustine 150 mg per square metre day 1 every other cycle, and tamoxifen 10 mg orally twice daily, every 3 weeks
- Dacarbazine (control): Dacarbazine 1,000 mg per square metre every 3 weeks
- People
- Chapman PB, senior author Kirkwood JM
Δ ORR+8.3 points
Show the numbers
| Endpoint | Analysis | Dartmouth regimen | Dacarbazine | Effect |
|---|---|---|---|---|
| ORRPatients with assessable tumour response (226) | primaryChapman 1999 | 18.5% | 10.2% | P=0.09The abstract reports no difference in survival time between the arms (analysed on an intention-to-treat basis and among the 231 eligible treated patients); median survival from randomisation across both arms was 7 months and 25% survived 1 year or longer. |
| Endpoint | Analysis | Dartmouth regimen | Dacarbazine | Effect |
|---|---|---|---|---|
| ORRPatients with assessable tumour response (226) | primaryChapman 1999 | 18.5% | 10.2% | P=0.09The abstract reports no difference in survival time between the arms (analysed on an intention-to-treat basis and among the 231 eligible treated patients); median survival from randomisation across both arms was 7 months and 25% survived 1 year or longer. |