Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07139990
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cohort A: Extensive Stage Small Cell Lung Cancer (ES-SCLC) Thoracic Tumor PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy) — RADIATION
    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)
  • Cohort B: Brain metastasis PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy) — RADIATION
    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
  • Cohort C: Sarcoma Pre-Operative PULSAR — RADIATION
    Pre-operative PULSAR with immunotherapy for localized soft tissue sarcoma Adaptive Changes Allowed: Tumor target (size/shape)
  • Cohort D: Resectable Head & Neck Squamous Cell Carcinoma (HNSCC) PULSAR/SAbR — RADIATION
    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)

Study Details

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

Key Dates

First listed
Aug 24, 2025
Start date
Oct 28, 2025
Status verified
Aug 2026
Primary completion
Sep 1, 2030
Completion
Sep 1, 2032

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: COHORT A (ES-SCLC PULSAR Thoracic Tumor):
    PULSAR with online adaptive planning to 7-10 Gy per fraction for up to 3 pulses directed at the bulkiest sites of disease in the thorax before infusion days (window: D-1 to D-4; optimal D-1) of three cycles of chemoimmunotherapy. The first radiotherapy pulse must be delivered before chemoimmunotherapy cycle 4. The three "pulses" of radiotherapy ideally should be given with consecutive cycles of systemic therapy. Radiotherapy can be suspended if a complete clinical response is reached before all 3 pulses are delivered. Chemoimmunotherapy will be given per standard of care
  • Experimental: COHORT B (Brain metastasis PULSAR):
    PULSAR will be delivered in a 2 "pulse" strategy: 1: Deliver fSRT/SRS every other day (minimum 48 hour separation between treatments, minimum 1 treatment per week;begin and complete within 60 days of registration) for 3 fractions. Pulse 1 must begin and complete within 60 days of registration; 2) Repeat treatment planning MRI will be performed after 4 weeks (window: +/-1 weeks) after fraction 3 and volumetric response assessment made; 3) Pulse 2 is omitted in those with \>=25% volumetric size reduction response. In others, pulse 2 will deliver fSRT/SRS every other day (minimum 48 hour separation between treatments, minimum 1 treatment per week). Pulse 2 may deliver higher dose per fraction within Section 4.1.3.4 specifications (Table 6), rationale for this would be for addressing lesions that either due to large size or proximity to critical structures could only be treated to a lower dose range in pulse 1. Pulse 2 must begin 4 weeks (+/-1 weeks) after end of Pulse 1.
  • Experimental: COHORT C (Sarcoma Pre-operative PULSAR)
    Patients will receive pembrolizumab infusion every 3 weeks for three doses starting the day after the first pulse of radiation and then synchronizing the day after the administration of each pulse of radiation. Adjuvant pembrolizumab may be given at physician discretion per standard of care. External beam radiation will be delivered to a dose of 24 Gy in pulses of 8 Gy each once every 3 weeks over a total of 9 weeks. Surgery will be performed 3-6 weeks after cycle 3 of immunotherapy.
  • Experimental: COHORT D (Resectable HNSCC PULSAR/SAbR):
    Random PULSAR or SAbR,by site.PULSAR:Each pulse of radiotherapy(RT)(8Gy)given to primary tumor/involved nodes using online adaptive RT plan.RT given 1-7 days before each pembrolizumab cycle,total of 3 pulses,3 weeks apart.Before 3rd pulse,repeat MRI \& PET simulation done.SAbR:Each fraction of RT(8 Gy)given to primary tumor/nodes using online adaptive RT plan.Total of 3 fractions of RT over 2 weeks,then 3 cycles of pembrolizumab done every 3 weeks.Both arms:adjuvant RT determined on surgical pathology \& risks of recurrence.Factors in primary tumor for adjuvant RT:pathologic T3/T4,positive/close(defined as \<3 mm)margins,lymphovascular invasion/perineural invasion.Factors in neck for adjuvant RT: \>1 lymph node,lymph nodes \>3 cm. Independent decision to treat primary site/lymph(either primary site/lymph treated based on criteria.)For adjuvant RT,primary site dose:60Gy in 30 fractions.Involved nodals:60Gy in 30 fractions.Uninvolved nodals:54Gy in 30 fractions.

Primary Outcome Measure

COHORT A-assess safety of addition of PULSAR radiotherapy to thoracic tumor in ES-SCLC alongside chemoimmunotherapy, while making preliminary/exploratory assessments of disease response and dosimetric benefit to PULSAR [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ut Southwestern Medical CenterDallasTexas75390
SARAH NEUFELD
[email protected]
214-648-1836
NEIL DESAI, MD
[email protected]
214 648 1836

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