Status:
RECRUITING
Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Small Cell Lung Cancer Extensive Stage
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To characterize feasibility, safety, and/or preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.
Detailed Description
Cohort-Specific Rationale COHORT A (ES-SCLC Personalized ultrahypofractionated stereotactic ablative radiotherapy (PULSAR) Thoracic Tumor): Chemoimmunotherapy with 4-6 cycles of platinum/etoposide a...
Eligibility Criteria
Inclusion
- 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 (1-5 lesions allowed) 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.
Exclusion
- Cohort A:
- ⨀ Prior thoracic Radiotherapy
- Cohort B:
- Prior whole brain Radiotherapy
- Prior surgical resection or focal radiotherapy of a target brain metastasis
- Leptomeningeal disease
Key Trial Info
Start Date :
October 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07139990
Start Date
October 28 2025
End Date
September 1 2030
Last Update
November 7 2025
Active Locations (1)
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1
Ut Southwestern Medical Center
Dallas, Texas, United States, 75390