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RECRUITING

NCT07139990

PHASE1

Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

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

Official title: Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2025-10-28

Completion Date

2032-09-01

Last Updated

2026-08-17

Healthy Volunteers

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)

Inclusion Criteria: Cohort A: * \>=18 years old * Performance status ECOG 0-2 * Extensive stage small cell lung cancer diagnosed by tissue biopsy within 180 days of registration. * Patient must be planned for or receiving standard of care chemoimmunotherapy. * Patient must have received no more than 3 cycles by time of study enrollment. * Able and indicated according to investigator to receive thoracic radiotherapy Cohort B: * 18 years old * Diagnosis of solid tumor malignancy with MRI-defined brain metastasis lesions within 60 days of registration * Each brain metastasis lesion enrolled must be 2 - 5 cm, except brainstem lesions which may be 1.5 - 5cm in size. Cohort C: * \>=18 years old * Performance status ECOG 0-2 * Histologically confirmed surgically resectable, high grade (FNCLCC grade 2 or 3), localized soft tissue sarcoma of the trunk or extremities that measures \>5 cm in any direction as assessed by imaging * Eligible to receive immunotherapy Cohort D: * \>=18 years old * Performance status ECOG 0-2 * Pathologically proven diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx * Clinical stage III/IVA (AJCC 8th edition) * Disease must be deemed resectable by head and neck surgeon * Eligible to receive immunotherapy Exclusion Criteria: Cohort A: ⨀ Prior thoracic Radiotherapy Cohort B: * Prior whole brain Radiotherapy * Prior surgical resection or focal radiotherapy of a target brain metastasis * Leptomeningeal disease Cohort C: * Unresectable or metastatic (nodal or distant) disease * Synchronous malignancy requiring chemotherapy or other intensive treatment * Locally recurrent soft tissue sarcoma * Prior immunotherapy * Pregnancy or breastfeeding Cohort D: * Distant metastasis * Inability to undergo PET-CT for baseline staging * HPV-positive or p16-positive oropharyngeal cancer * Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable * Prior immunotherapy for the study cancer or for a remote cancer * Prior head and neck radiotherapy

Locations (1)

Ut Southwestern Medical Center

Dallas, Texas, United States

Clinical Research Directory

Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)