Clinical trial · Interventional
Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS
PROTONS-RPS: a Phase II Non-Randomized Open-label Single-arm Trial Of Neoadjuvant Short-course Hypofractionated Proton Beam Therapy for Non-metastatic RetroPeritoneal Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): withdrawn by PI
Summary
Brief summary (as posted)
The investigators' study titled "PROTONS-RPS: a Phase II non-Randomized Open-label single-arm Trial Of Neoadjuvant Short-course hypofractionated proton beam therapy for non-metastatic RetroPeritoneal Sarcoma" is a phase II trial evaluating the safety and efficacy of hypofractionated proton beam therapy (H-PBT) in the neoadjuvant (NA) setting for patients with non-metastatic retroperitoneal sarcoma (RPS) planned for surgical resection. This trial will include adult patients with resectable RPS.
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 |
|---|---|---|---|
| Hypofractionated Proton Beam Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Proton Beam Therapy
- description
- 5 fractions of 5 Gy of PBT to clinical tumor volume +/- an additional simultaneous 1 Gy per fraction to any pre-determined at-risk margin (for a total of 6 Gy per fraction x 5 fractions for at-risk margins as a simultaneous integrated boost (SIB)).
- interventionNames
- Radiation: Hypofractionated Proton Beam Therapy
Primary outcomes (1)
- measure
- Overall serious adverse event rate for patients with primary resectable RPS receiving NA short-course h-PBT followed by surgical resection
- timeFrame
- 24 months
- description
- Incidence of acute Grade 3+ adverse events after PBT and surgical resection during median follow-up based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (≥18 years of age) * Patients with primary non-recurrent retroperitoneal sarcoma * Calculated creatinine clearance ≥50 mL/min and functional contralateral kidney based on nuclear medicine renal scan * Normal bone marrow function (WBC ≥ 4 x109 /L) * Eastern Cooperative Oncology Group status ≤ 2 * Cardiac function ≤ New York Heart Association class II * Proton beam therapy approved by insurance (including Medicare/Medicaid) Exclusion Criteria: * Evidence of metastatic disease on staging CT of chest/abdomen/pelvis * History of abdominal or pelvic radiation therapy * Inability to tolerate supine position for duration of PBT simulation or treatment * Tumor originating from gastrointestinal or gynecologic organs * Specific sarcoma histologies including osteosarcoma, desmoid tumors, chondrosarcoma arising from vertebrae or pelvic bones, embryonal rhabdomyosarcoma * Tumor extending into femoral or obturator canal * History of systemic lupus erythematosus or ulcerative colitis * Genetic syndrome with radiation-associated tumorigenicity (i.e.: Li-Fraumeni) * Presence of clinically significant ascites * Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators.
References
Publications (0)
Data not yet available