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STRASS

Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial

Phase 3N = 266NCT01344018

Population
266 adults with histologically documented, localised, primary, operable retroperitoneal sarcoma suitable for radiotherapy, previously untreated, WHO performance status and ASA score of 2 or lower
Design
Open-label, randomised (1:1, minimisation) phase 3 trial in 31 institutions in 13 countries, 18 January 2012 to 10 April 2017; stratified by hospital and performance status. Radiotherapy 50.4 Gy in 28 daily fractions of 1.8 Gy (3D conformal or intensity-modulated), then surgery aiming at macroscopically complete en-bloc resection. Median follow-up 43.1 months.
Primary endpoint
Abdominal recurrence-free survival
Arms
  • Surgery alone (control, n = 133): Surgery with macroscopically complete en-bloc resection as the objective
  • Preoperative radiotherapy plus surgery (experimental, n = 133): Radiotherapy 50.4 Gy in 28 fractions of 1.8 Gy, followed by surgery
People
Bonvalot S
Abdominal recurrence-free survivalHR 1.01 (95% CI 0.71–1.44)Δ median Abdominal recurrence-free survival−0.5 years
Show the numbers
Results reported for STRASS
EndpointAnalysisPreoperative radiotherapy plus surgerySurgery aloneEffect
Abdominal recurrence-free survivalprimarymedian follow-up 43.1 monthsBonvalot 2020median 4.5 yearsmedian 5 yearsHR 1.01 (95% CI 0.71–1.44)P=0.95Investigator-assessed. The 95% CIs for the median are 3.9 to not estimable (radiotherapy plus surgery) and 3.4 to not estimable (surgery alone); log-rank test.
Results reported for STRASS
EndpointAnalysisPreoperative radiotherapy plus surgerySurgery aloneEffect
Abdominal recurrence-free survivalprimarymedian follow-up 43.1 monthsBonvalot 2020median 4.5 yearsmedian 5 yearsHR 1.01 (95% CI 0.71–1.44)P=0.95Investigator-assessed. The 95% CIs for the median are 3.9 to not estimable (radiotherapy plus surgery) and 3.4 to not estimable (surgery alone); log-rank test.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
Abdominal recurrence-free survival0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
Abdominal recurrence-free survival1.010.71–1.44
Illustrative — modelled from reported values, not trial data. Abdominal recurrence-free survival, primary.
0%25%50%75%100%020406080100120140Months (modelled)
  • Preoperative radiotherapy plus surgery (experimental)
  • Surgery alone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsPreoperative radiotherapy plus surgerySurgery alone
0100.0%100.0%
3861.4%64.5%
7538.2%42.0%
11323.4%27.1%
15014.6%17.7%
Primary publication: Bonvalot S, Gronchi A, Le Péchoux C, Swallow CJ, Strauss D, Meeus P, et al. Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020;21(10):1366-1377. PubMedDOI

Appears in

Sources

  1. Bonvalot S, Gronchi A, Le Péchoux C, Swallow CJ, Strauss D, Meeus P, et al. Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020;21(10):1366-1377.

    PubMedDOI