Clinical trial · Interventional
Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma
A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)
NCT01344018CI-TRIAL-00065887STRASScompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery alone
- description
- En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
- interventionNames
- Procedure: therapeutic conventional surgery
- type
- EXPERIMENTAL
- label
- Preoperative radiotherapy followed by en-bloc surgery
- description
- 3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
- interventionNames
- Procedure: therapeutic conventional surgery
- Radiation: 3-dimensional conformal radiation therapy
Primary outcomes (1)
- measure
- Number of Patients With Abdominal Recurrence or Death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed retroperitoneal sarcoma (RPS) by local pathologist, imaging-guided or surgical biopsy, including the following:
* Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis
* Sarcoma not originated from bone structure, abdominal, or gynecological viscera
* Unifocal tumor (not multifocal disease)
* Absence of extension through the sciatic notch or across the diaphragm
* The following histological sub-types are not allowed:
* Gastrointestinal stromal tumor (GIST)
* Rhabdomyosarcomas
* Primitive neuroectodermal tumor (PNET) or other small round blue cells sarcoma
* Osteosarcoma or chondrosarcoma
* Aggressive fibromatosis
* Sarcomatoid or metastatic carcinoma
* No metastatic disease
* Untreated disease
* Tumor must be operable and suitable for radiotherapy, based on the following criteria:
* Pre-treatment CT scan/MRI and multidisciplinary consultation with surgeon, radiation oncologist, and radiologist (anticipated macroscopically complete resection, R0/R1 resection)
* No surgery anticipated to be R2 on the CT scan before randomization
* Must have American Society of Anesthesiologist (ASA) score ≤ 2
* None of the following unresectable criteria:
* Involvement of superior mesenteric artery
* Involvement of aorta
* Involvement of bone
* Must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT (with IV and PO contrast) or MRI (with IV contrast)
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* WBC ≥ 2,500/mm\^3
* Platelet count ≥ 80,000/mm\^3
* Total bilirubin \< 1.5 times the upper limit normal
* Calculated creatinine clearance normal
* Functional contra-lateral kidney to the side involved by the RPS as assessed by intravenous pyelogram
* Adequate cardiac function (NYHA class I-II)
* ECG normal (without clinically significant abnormalities)
* No history of any of the following disorders:
* Bowel obstruction
* Mesenteric ischemia
* Severe chronic inflammatory bowel disease
* Negative pregnancy test
* Not pregnant or nursing concurrently and for at least 1 month after the surgery
* Fertile patients must use effective contraception during the study treatment period and for at least 1 month after the surgery
* No co-existing malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
* No prior surgery (excluding diagnosis biopsy), radiotherapy, or systemic therapy
* No prior abdominal or pelvic irradiation for another prior malignancy or other disease
* No concurrent systemic anticancer treatment (chemotherapy, molecular-targeted therapy)
* No postoperative radiotherapy plannedReferences
Publications (1)
- DERIVEDBonvalot S, Gronchi A, Le Pechoux C, Swallow CJ, Strauss D, Meeus P, van Coevorden F, Stoldt S, Stoeckle E, Rutkowski P, Rastrelli M, Raut CP, Hompes D, De Paoli A, Sangalli C, Honore C, Chung P, Miah A, Blay JY, Fiore M, Stelmes JJ, Dei Tos AP, Baldini EH, Litiere S, Marreaud S, Gelderblom H, Haas RL. 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. doi: 10.1016/S1470-2045(20)30446-0. Epub 2020 Sep 14. PMID 32941794