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Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)

NCT07139990 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-08-17

No results posted yet for this study

Summary

To characterize feasibility, safety, and/or preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.

Conditions

  • Small Cell Lung Cancer Extensive Stage
  • Brain Metastases
  • Solid Tumor, Adult
  • Thoracic Cancer
  • Sarcoma,Soft Tissue
  • HNPCC

Interventions

RADIATION

Cohort A: Extensive Stage Small Cell Lung Cancer (ES-SCLC) Thoracic Tumor PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)

Radiographic response-adapted thoracic tumor radiotherapy given as single doses ('pulses') before standard of care chemoimmunotherapy cycles. Adaptive Changes Allowed: Tumor target (size/shape), # of doses (reduction) Adaptive Changes Allowed: Tumor target (size/shape), # of doses (reduction)

RADIATION

Cohort B: Brain metastasis PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)

Fractionated stereotactic radiosurgery (SRS, 5 doses total) for brain metastasis given in two "pulses" (3 fractions + 2 fractions) with second pulse adapted to interim radiographic response Adaptive Changes Allowed: Omission of 2nd "pulse" in \>=25% responders or tumor target size/shape change in remainder

RADIATION

Cohort C: Sarcoma Pre-Operative PULSAR

Pre-operative PULSAR with immunotherapy for localized soft tissue sarcoma Adaptive Changes Allowed: Tumor target (size/shape)

RADIATION

Cohort D: Resectable Head & Neck Squamous Cell Carcinoma (HNSCC) PULSAR/SAbR

Neoadjuvant immunotherapy \& radiation given as either PULSAR (3 "pulses") or SAbR (3 fractions) prior to resection for HNSCC Adaptive Changes Allowed: Tumor and nodal target (size/shape)

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • NEIL DESAI, MD, MHS · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2030-09-01
Completion
2032-09-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT07139990 on ClinicalTrials.gov