NSABP R-04
A clinical trial comparing preoperative radiation therapy and capecitabine with or without oxaliplatin with preoperative radiation therapy and continuous intravenous infusion of 5-fluorouracil with or without oxaliplatin in the treatment of patients with operable carcinoma of the rectum
Phase 3N = 1,608NCT00058474
- Population
- Patients with clinical stage II or III rectal cancer undergoing preoperative radiation
- Design
- Randomised phase 3 trial with a 2x2 design in patients with clinical stage II or III rectal cancer undergoing preoperative radiation (45 Gy in 25 fractions over 5 weeks plus a boost of 5.4 to 10.8 Gy in three to six daily fractions): continuous intravenous infusion fluorouracil (225 mg/m2, 5 days per week) or oral capecitabine (825 mg/m2 twice per day, 5 days per week), each with or without weekly oxaliplatin (50 mg/m2 for 5 weeks). 1608 patients were randomised between September 2004 and August 2010. Results for oxaliplatin are given across both fluoropyrimidines.
- Primary endpoint
- Local-regional tumour control
- Arms
- No oxaliplatin (control): Preoperative radiation with infusional fluorouracil or capecitabine, without oxaliplatin (both fluoropyrimidine arms combined)
- With oxaliplatin (experimental): Preoperative radiation with infusional fluorouracil or capecitabine plus weekly oxaliplatin 50 mg/m2 for 5 weeks (both fluoropyrimidine arms combined)
- People
- Allegra CJ
Locoregional failureHR 0.94DFSHR 0.91Δ 60-month DFS+5 pointsOSHR 0.89Δ 60-month OS+2.3 points
Show the numbers
| Endpoint | Analysis | With oxaliplatin | No oxaliplatin | Effect |
|---|---|---|---|---|
| Locoregional failureRandomised patients (1608); oxaliplatin comparison across both fluoropyrimidinesThree-year local-regional tumour event rate, oxaliplatin versus no oxaliplatin (the primary endpoint was local-regional tumour control) | finalAllegra 2015 | — | — | HR 0.94P=0.70No statistically significant difference between the use and nonuse of oxaliplatin (HR 0.94, P=.70; no confidence interval or reference arm is stated in the text). The two 3-year rates (11.2% and 12.1%) are not assigned to arms here because the abstract and the Results text list them in opposite order. Three-year rates of local-regional recurrence among patients who had an R0 resection ranged from 3.1 to 5.1% depending on the study arm. |
| DFSRandomised patients (1608); analysis population not stated in the abstract5-year disease-free survival | finalAllegra 2015 | 69.2% at 5 y | 64.2% at 5 y | HR 0.91P=0.34No statistically significant difference (HR 0.91, P=.34 in the Results text; no confidence interval or reference arm is stated there). Oxaliplatin comparison across both fluoropyrimidines. |
| OSRandomised patients (1608); analysis population not stated in the abstract5-year overall survival | finalAllegra 2015 | 81.3% at 5 y | 79% at 5 y | HR 0.89P=0.38No statistically significant difference (HR 0.89, P=.38 in the Results text; no confidence interval or reference arm is stated there). The 2016 erratum corrected the hazard ratio in Figure 5B to 0.89. Oxaliplatin comparison across both fluoropyrimidines. |
| Endpoint | Analysis | With oxaliplatin | No oxaliplatin | Effect |
|---|---|---|---|---|
| Locoregional failureRandomised patients (1608); oxaliplatin comparison across both fluoropyrimidinesThree-year local-regional tumour event rate, oxaliplatin versus no oxaliplatin (the primary endpoint was local-regional tumour control) | finalAllegra 2015 | — | — | HR 0.94P=0.70No statistically significant difference between the use and nonuse of oxaliplatin (HR 0.94, P=.70; no confidence interval or reference arm is stated in the text). The two 3-year rates (11.2% and 12.1%) are not assigned to arms here because the abstract and the Results text list them in opposite order. Three-year rates of local-regional recurrence among patients who had an R0 resection ranged from 3.1 to 5.1% depending on the study arm. |
| DFSRandomised patients (1608); analysis population not stated in the abstract5-year disease-free survival | finalAllegra 2015 | 69.2% at 5 y | 64.2% at 5 y | HR 0.91P=0.34No statistically significant difference (HR 0.91, P=.34 in the Results text; no confidence interval or reference arm is stated there). Oxaliplatin comparison across both fluoropyrimidines. |
| OSRandomised patients (1608); analysis population not stated in the abstract5-year overall survival | finalAllegra 2015 | 81.3% at 5 y | 79% at 5 y | HR 0.89P=0.38No statistically significant difference (HR 0.89, P=.38 in the Results text; no confidence interval or reference arm is stated there). The 2016 erratum corrected the hazard ratio in Figure 5B to 0.89. Oxaliplatin comparison across both fluoropyrimidines. |