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Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS

NCT05302570 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-12-15

No results posted yet for this study

Summary

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

  • Retroperitoneal Sarcoma

Interventions

RADIATION

Hypofractionated Proton Beam Therapy

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)).

Sponsors & Collaborators

  • Robert L. Sloan Fund for Cancer Research

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Amol Narang, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05302570 on ClinicalTrials.gov