EORTC-62092 STRASS
Trial question
What is the role of preoperative radiotherapy plus surgery in patients with primary retroperitoneal sarcoma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 266
266 patients (128 female, 138 male).
Inclusion criteria: adult patients with histologically documented, localized, primary retroperitoneal sarcoma.
Key exclusion criteria: macroscopically incomplete surgery; gastrointestinal stromal tumor, rhabdomyosarcoma; primitive neuroectodermal tumor or other small round blue cell sarcoma; osteosarcoma; chondrosarcoma; aggressive fibromatosis; sarcomatoid or metastatic carcinoma.
Interventions
N=133 preoperative radiotherapy plus surgery (preoperative radiotherapy delivered as 50.4 Gy in 28 daily fractions of 1.8 Gy plus complete resection of the tumor mass with en-bloc organ resection as necessary).
N=133 surgery alone (macroscopically complete resection of the tumor mass with en-bloc organ resection as necessary).
Primary outcome
Median abdominal recurrence-free survival
4.5 years
5 years
5.0 years
3.8 years
2.5 years
1.3 years
0.0 years
Preoperative radiotherapy plus
surgery
Surgery
alone
No significant
difference ↔
No significant difference in median abdominal recurrence-free survival (4.5 years vs. 5 years; HR 1.01, 95% CI 0.71 to 1.44).
Secondary outcomes
No significant difference in metastasis-free survival at 3 years (68.3% vs. 68.2%; HR 0.89, 95% CI 0.58 to 1.36).
No significant difference in abdominal recurrence-free interval at 3 years (34.3% vs. 32%; HR 1.09, 95% CI 0.74 to 1.6).
Safety outcomes
No significant difference in anemia.
Significant difference in lymphopenia (77% vs. 1%).
Conclusion
In adult patients with histologically documented, localized, primary retroperitoneal sarcoma, preoperative radiotherapy plus surgery was not superior to surgery alone with respect to median abdominal recurrence-free survival.
Reference
Sylvie Bonvalot, Alessandro Gronchi, Cécile Le Péchoux 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 Oct;21(10):1366-1377.
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