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Bending the Curve Trial by Trial
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TROG 01.04

A randomised trial of preoperative radiotherapy for stage T3 adenocarcinoma of rectum

Phase 3N = 326NCT00145769

Population
Patients with ultrasound- or MRI-staged T3N0-2M0 rectal adenocarcinoma within 12 cm of the anal verge
Design
Randomised trial in patients with ultrasound- or MRI-staged T3N0-2M0 rectal adenocarcinoma within 12 cm of the anal verge. Short-course: pelvic radiotherapy 5 x 5 Gy in 1 week, early surgery and six courses of adjuvant chemotherapy. Long-course: 50.4 Gy at 1.8 Gy per fraction over 5.5 weeks with continuous infusional fluorouracil 225 mg/m2 per day, surgery 4 to 6 weeks later and four courses of chemotherapy. 326 patients were randomised (163 and 163); median potential follow-up was 5.9 years (range 3.0 to 7.8).
Primary endpoint
Local recurrence
Arms
  • Short-course radiotherapy (control, n = 163): Pelvic radiotherapy 5 x 5 Gy in 1 week, early surgery, then six courses of adjuvant chemotherapy
  • Long-course chemoradiation (experimental, n = 163): 50.4 Gy at 1.8 Gy per fraction over 5.5 weeks with continuous infusional fluorouracil 225 mg/m2 per day, surgery 4 to 6 weeks later, then four courses of chemotherapy
People
Ngan SY
Δ 36-month Local recurrence−3.1 pointsDistant recurrenceHR 1.04 (95% CI 0.69–1.56)Δ 60-month Distant recurrence+3 pointsOSHR 1.12 (95% CI 0.76–1.67)Δ 60-month OS−4 pointsΔ Grade 3-4 late toxicity+2.4 points
Show the numbers
Results reported for TROG 01.04
EndpointAnalysisLong-course chemoradiationShort-course radiotherapyEffect
Local recurrenceRandomised patients (326); analysis population not stated in the abstract3-year local recurrence rate (cumulative incidence)primarymedian follow-up 5.9 yearsNgan 20124.4% at 3 y7.5% at 3 yP=0.24Difference 3.1% (95% CI -2.1 to 8.3). For distal tumours (< 5 cm), local recurrence occurred in 6 of 48 short-course patients and 1 of 31 long-course patients (P=0.21). The median potential follow-up was 5.9 years (range 3.0 to 7.8).
Distant recurrenceRandomised patients (326); analysis population not stated in the abstract5-year distant recurrence rate; hazard ratio is long-course relative to short-courseprimaryNgan 201230% at 5 y27% at 5 yHR 1.04 (95% CI 0.69–1.56)P=0.92
OSRandomised patients (326); analysis population not stated in the abstract5-year overall survival; hazard ratio is long-course relative to short-courseprimaryNgan 201270% at 5 y74% at 5 yHR 1.12 (95% CI 0.76–1.67)P=0.62
Grade 3-4 late toxicityRandomised patients (326); analysis population not stated in the abstractLate toxicity, RTOG/EORTC grade 3-4primaryNgan 20128.2%5.8%P=0.53
Results reported for TROG 01.04
EndpointAnalysisLong-course chemoradiationShort-course radiotherapyEffect
Local recurrenceRandomised patients (326); analysis population not stated in the abstract3-year local recurrence rate (cumulative incidence)primarymedian follow-up 5.9 yearsNgan 20124.4% at 3 y7.5% at 3 yP=0.24Difference 3.1% (95% CI -2.1 to 8.3). For distal tumours (< 5 cm), local recurrence occurred in 6 of 48 short-course patients and 1 of 31 long-course patients (P=0.21). The median potential follow-up was 5.9 years (range 3.0 to 7.8).
Distant recurrenceRandomised patients (326); analysis population not stated in the abstract5-year distant recurrence rate; hazard ratio is long-course relative to short-courseprimaryNgan 201230% at 5 y27% at 5 yHR 1.04 (95% CI 0.69–1.56)P=0.92
OSRandomised patients (326); analysis population not stated in the abstract5-year overall survival; hazard ratio is long-course relative to short-courseprimaryNgan 201270% at 5 y74% at 5 yHR 1.12 (95% CI 0.76–1.67)P=0.62
Grade 3-4 late toxicityRandomised patients (326); analysis population not stated in the abstractLate toxicity, RTOG/EORTC grade 3-4primaryNgan 20128.2%5.8%P=0.53
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
Distant recurrenceOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
Distant recurrence1.040.69–1.56
OS1.120.76–1.67
Primary publication: Ngan SY, Burmeister B, Fisher RJ, Solomon M, Goldstein D, Joseph D, et al. Randomized trial of short-course radiotherapy versus long-course chemoradiation comparing rates of local recurrence in patients with T3 rectal cancer: Trans-Tasman Radiation Oncology Group trial 01.04. J Clin Oncol. 2012;30(31):3827-33. PubMedDOI

Appears in

Sources

  1. Ngan SY, Burmeister B, Fisher RJ, Solomon M, Goldstein D, Joseph D, et al. Randomized trial of short-course radiotherapy versus long-course chemoradiation comparing rates of local recurrence in patients with T3 rectal cancer: Trans-Tasman Radiation Oncology Group trial 01.04. J Clin Oncol. 2012;30(31):3827-33.

    PubMedDOI