NCIC cervix trial
Phase III trial comparing radical radiotherapy with and without cisplatin chemotherapy in patients with advanced squamous cell cancer of the cervix
Phase 3N = 259
- Population
- FIGO stage IB to IVA squamous cell cervical cancer with central disease of at least 5 cm or histologically confirmed pelvic lymph-node involvement (253 of 259 randomised patients analysed)
- Design
- Randomised phase III trial: radical radiotherapy (external-beam plus brachytherapy) with weekly cisplatin 40 mg/m2 (arm 1) or the same radiotherapy without chemotherapy (arm 2). 259 patients were randomised and 253 were available for analysis.
- Arms
- Radiotherapy with weekly cisplatin (arm 1) (experimental): External-beam radiotherapy plus brachytherapy with weekly cisplatin 40 mg/m2
- Radiotherapy alone (arm 2) (control): External-beam radiotherapy plus brachytherapy without chemotherapy
- People
- Pearcey R, senior author Tu D
Δ 36-month OS+3 points
Show the numbers
| Endpoint | Analysis | Radiotherapy with weekly cisplatin (arm 1) | Radiotherapy alone (arm 2) | Effect |
|---|---|---|---|---|
| OSPatients available for analysis (253 of 259 randomised) | primarymedian follow-up 82 monthsPearcey 2002 | 69% at 3 y; 62% at 5 y | 66% at 3 y; 58% at 5 y | P=0.42No significant difference in progression-free survival (P = .33; no per-arm values in the abstract). The hazard ratio for survival is published as arm 2 to arm 1, 1.10 (95% CI 0.75 to 1.62), where arm 1 is radiotherapy with cisplatin and arm 2 is radiotherapy alone; that direction is the inverse of the usual experimental-versus-control convention, so it is kept here and not in the hazard-ratio field. |
| Endpoint | Analysis | Radiotherapy with weekly cisplatin (arm 1) | Radiotherapy alone (arm 2) | Effect |
|---|---|---|---|---|
| OSPatients available for analysis (253 of 259 randomised) | primarymedian follow-up 82 monthsPearcey 2002 | 69% at 3 y; 62% at 5 y | 66% at 3 y; 58% at 5 y | P=0.42No significant difference in progression-free survival (P = .33; no per-arm values in the abstract). The hazard ratio for survival is published as arm 2 to arm 1, 1.10 (95% CI 0.75 to 1.62), where arm 1 is radiotherapy with cisplatin and arm 2 is radiotherapy alone; that direction is the inverse of the usual experimental-versus-control convention, so it is kept here and not in the hazard-ratio field. |
- Radiotherapy with weekly cisplatin (arm 1) (experimental)
- Radiotherapy alone (arm 2) (control)
Data table (modelled values)
| Months | Radiotherapy with weekly cisplatin (arm 1) | Radiotherapy alone (arm 2) |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 16 | 85.1% | 83.7% |
| 32 | 71.5% | 68.8% |
| 49 | 64.4% | 60.8% |
| 65 | 62.0% | 58.0% |