Clinical trial · Interventional
The PET- Retroperitoneal Sarcoma Study
The PET-RPS Study: Utility of PET for Assessment of Response to Preoperative Chemotherapy in Primary Retroperitoneal Sarcoma (RPS)
- 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)
Retroperitoneal sarcoma(RPS) is a rare cancer that is difficult to cure as it typically presents as a very large abdominal mass, and complete removal with clear margins is challenging . This study will focus on improving the outcomes of surgery by treating RPS before surgery, to make resection more effective. The role of chemotherapy as a preoperative treatment for RPS is highly controversial. Response to chemotherapy is unpredictable and if the patient's tumour progresses instead of responding, the window of opportunity for resection will be lost. Conventional cross sectional imaging (CT scan) is inadequate to measure response to chemotherapy until 5-6 cycles have been given, possibly with no improvement. Thus it is critical to develop an earlier and reliable way to assess response. Functional imaging by PET scan is used in other tumour types to identify early response to treatment. PET imaging may provide a more meaningful assessment of RPS response to systemic therapy much earlier in the course of treatment than conventional imaging, allowing timely modification of the treatment plan. This study will define the role of PET imaging in evaluating early response to systemic therapy in high grade RPS, improving patient treatment.
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 |
|---|---|---|---|
| Retroperitoneal Sarcoma | Retroperitoneal Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET MRI scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET-MR arm
- description
- Every eligible patient will be scanned by PET-MR at baseline and following 1 cycle of chemotherapy. PET-CT at baseline will also be obtained as it is the current standard of care and will be used to determine trial eligibility (no evidence metastasis at baseline).
- interventionNames
- Device: PET MRI scan
Primary outcomes (1)
- measure
- Correlation of PET imaging with histologic response following preoperative chemotherapy.
- timeFrame
- 3 years
- description
- Pathology of RPS specimens, resected following standard ifosfamide/doxorubicin chemotherapy every 3 weeks for 5-6 cycles, will be compared with PET response (FDG uptake) after cycle 1 of chemotherapy.
Secondary outcomes (1)
- measure
- Correlation of CT imaging with histologic response, and comparing prognostic accuracy of PET-MR vs.CT imaging for histologic response, recurrence status, and survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Tumour-related criteria * Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis * Sarcoma not originated from bone structure, abdominal or gynecological viscera * Unifocal tumour (not multifocal disease) * Absence of extension through the sciatic notch or across the diaphragm * Histologically-proven RPS (local pathologist/ imaging-guided or surgical biopsy), only including the following histological sub-types: * High grade Leiomyosarcoma * High grade Dedifferentiated Liposarcoma * Tumour not previously treated (no previous surgery -excluding diagnosis biopsy-, radiotherapy or systemic therapy) * Tumour both operable and suitable for chemotherapy (This will be based on pretreatment CT scan/MRI and multidisciplinary consultation with surgeon medical oncologist and radiologist (anticipated macroscopically complete resection, R0/R1resection) * Patients for whom surgery is expected to be R2 on the CT-scan before randomization are not eligible * Patients must have American Society of Anesthesiologist (ASA) score ≤ 2 (see Appendix G) * The criteria for non-resectability are: * (i) involvement of superior mesenteric artery * (ii) involvement of aorta * (iii) involvement of bone * distant metastatic disease * Patient must have radiologically measurable disease (RECIST 1.1) Patient-related criteria * ≥ 18 years' old * WHO performance status ≤ 2 (see Appendix C) * Absence of history of bowel obstruction or mesenteric ischemia or severe chronic inflammatory bowel disease * Normal renal function: * Calculated creatinine clearance within normal value Functional contra-lateral kidney to the side involved by the RPS as assessed by intravenous pyelogram (done during the baseline CT-scan) or differential renal isotope scan * Normal bone marrow and hepatic function: * White Blood cells ≥ 2.5 x10 9 cells/L * Platelets ≥ 80 x10 9 cells/L * Total bilirubin \< 1.5 time the institutional upper limit normal of value (ULN) * Adequate cardiac function: less or equal to NYHA II * Normal 12 lead ECG (without clinically significant abnormalities) * No co-existing malignancy within the last 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix * No prior abdominal or pelvic irradiation for other prior malignancy or other disease * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Excluding patients who presented after incomplete resection and underwent immediate completion surgery. Exclusion Criteria: * Age\< 18 years * Recurrent tumour * Benign retroperitoneal tumours * Presence of second active cancer * Serious psychiatric disease that precludes informed consent or limits compliance * impossible to ensure adequate follow up
References
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