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NCT06327477 · ClinicalTrials.gov registry record · Phase 1
Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma
A Phase 1 study of Retroperitoneal Sarcoma, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT06327477: Recruiting Phase 1 study of Retroperitoneal Sarcoma, sponsored by Northwestern University.
NCT06327477 is a Phase 1 study of Retroperitoneal Sarcoma that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 28 participants, below the 411-participant average among 6 other Retroperitoneal Sarcoma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06327477, a Phase 1 study of Retroperitoneal Sarcoma, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of proton-spatially fractionated radiotherapy (P-SFRT) and to see how well it works with standard radiation therapy in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard spatially fractionated radiotherapy (SFRT) refers to how the radiation is delivered to the tumor. SFRT means that different parts of the tumor are receiving different doses of radiation (fractionation) through beams that allow areas of higher and lower (peaks and valleys) of doses of the radiation. This spatial fractionation allows an overall high-dose radiation to be given in the peaks and those areas of the tumor may release cells and substances that may help with killing tumor cells, reducing tumor symptoms and shrinking tumors. Proton therapy is a type of radiation therapy that can overcome some of the barriers of standard SFRT. Protons are tiny radioactive particles that can be controlled in a beam to travel up to the tumor and, compared to the particles used in standard radiotherapy, proton therapy can deliver higher doses to the tumor because smaller doses of radiation are delivered to tissues away from the tumor. This allows radiation therapy dose-escalated (continuously increasing the dose of radiation) treatment to tumors even though the tumor is near radiation sensitive organs like the colon. Giving P-SFRT with standard radiation therapy may work better in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma.
Primary Outcome
Will be defined as the highest dose with a dose-limiting toxicity (DLTs) as determined in phase I using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0). The DLT will be considered toxic and the prior dose will be considered the MTD (maximum tolerated dose). For the purposes of this protocol, the MTD will be the recommended phase II dose (RP2D).
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- RADIATION Intensity-Modulated Radiation Therapy
- PROCEDURE Resection
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-04-02 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 1 |
What NCT06327477 shows while recruiting
NCT06327477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 411-participant average among 6 other Retroperitoneal Sarcoma trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Retroperitoneal Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06327477 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06327477 about?
NCT06327477 is a clinical study titled "Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma". This phase I/II trial studies the side effects and best dose of proton-spatially fractionated radiotherapy (P-SFRT) and to see how well it works with standard radiation therapy in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma. Radiation therapy uses high energy x-rays, p...
What is the current status of trial NCT06327477?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2024-04-02. Estimated completion is 2028-07-01.
What conditions does trial NCT06327477 study?
This clinical trial studies the following conditions: Retroperitoneal Sarcoma.
What interventions are being tested in trial NCT06327477?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Intensity-Modulated Radiation Therapy (RADIATION), Resection (PROCEDURE).
Who is sponsoring clinical trial NCT06327477?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06327477 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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