STAR-01
Primary tumor response to preoperative chemoradiation with or without oxaliplatin in locally advanced rectal cancer: pathologic results of the STAR-01 randomized phase III trial
Phase 3N = 747
- Population
- Patients with resectable, locally advanced (cT3-4 and/or cN1-2) adenocarcinoma of the mid-low rectum
- Design
- Randomised phase 3 trial in 747 patients with resectable, locally advanced (cT3-4 and/or cN1-2) adenocarcinoma of the mid-low rectum. Pelvic radiation (50.4 Gy in 28 daily fractions) with concomitant infused fluorouracil (225 mg/m2 per day) either alone (arm A, n=379) or combined with oxaliplatin (60 mg/m2 weekly for six weeks; arm B, n=368). Overall survival is the primary end point; the 2011 paper reports the protocol-planned analysis of response to preoperative treatment.
- Primary endpoint
- OS
- Arms
- Chemoradiation with fluorouracil (arm A) (control, n = 379): Pelvic radiation 50.4 Gy in 28 daily fractions with infused fluorouracil 225 mg/m2 per day
- Chemoradiation with fluorouracil and oxaliplatin (arm B) (experimental, n = 368): Pelvic radiation 50.4 Gy in 28 daily fractions with infused fluorouracil 225 mg/m2 per day and oxaliplatin 60 mg/m2 weekly for six weeks
- People
- Aschele C
Δ pCR0 pointsΔ Grade 3-4 acute toxicity+16 points
Show the numbers
| Endpoint | Analysis | Chemoradiation with fluorouracil and oxaliplatin (arm B) | Chemoradiation with fluorouracil (arm A) | Effect |
|---|---|---|---|---|
| pCRRandomised patients (747); analysis population not stated in the abstractPathologic complete response (protocol-planned analysis of response to preoperative treatment) | primaryAschele 2011 | 16% | 16% | P=0.904Odds ratio 0.98 (95% CI 0.66-1.44). Overall survival, the primary end point, is not reported in this paper. |
| Grade 3-4 acute toxicityPatients treated (as stated in the abstract: percentage of treated patients)Grade 3-4 adverse events during preoperative treatment | primaryAschele 2011 | 24% | 8% | P<0.001Radiation dose of 45 Gy or more was received by 91% in the oxaliplatin arm and 97% in the control arm (P<.001); 83% of oxaliplatin-arm patients had five or more weekly administrations. |
| Endpoint | Analysis | Chemoradiation with fluorouracil and oxaliplatin (arm B) | Chemoradiation with fluorouracil (arm A) | Effect |
|---|---|---|---|---|
| pCRRandomised patients (747); analysis population not stated in the abstractPathologic complete response (protocol-planned analysis of response to preoperative treatment) | primaryAschele 2011 | 16% | 16% | P=0.904Odds ratio 0.98 (95% CI 0.66-1.44). Overall survival, the primary end point, is not reported in this paper. |
| Grade 3-4 acute toxicityPatients treated (as stated in the abstract: percentage of treated patients)Grade 3-4 adverse events during preoperative treatment | primaryAschele 2011 | 24% | 8% | P<0.001Radiation dose of 45 Gy or more was received by 91% in the oxaliplatin arm and 97% in the control arm (P<.001); 83% of oxaliplatin-arm patients had five or more weekly administrations. |