NCT07139990 · University of Texas Southwestern Medical Center
Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)
(PRISM)
What this study is about
To characterize feasibility, safety, and/or preliminary effectiveness of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.
View original scientific description
To characterize feasibility, safety, and/or preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.
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)
Primary outcome measures
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
Primary objective will be to report safety of PULSAR with chemoimmunotherapy for extensive stage small cell lung cancer. Accrual goal will be 15 patients.Study is interested in precise estimates of safety as well as outcome variability that will aid in the planning of larger, sufficiently powered efficacy trial. Sample size of 15 patients will allow for relative precision in conclusions regarding safety outcome.Namely,if 4 out of 15 patients enrolled are observed as having grade 3+ cardiopulmonary acute toxicity,the 95% CI for that rate would be (7.95%-55.10%) using an Exact (Clopper-Pearson) binomial confidence interval. Descriptive statistics according to variable type (continuous, categorical) will be used for reporting the cohort characteristics. Primary endpoint of pre-defined high grade toxicities will be reported as a categorical percentage.Disease control(time to event variables) will be reported by Kaplan-Meier estimates.
COHORT B-assesses ability to de-escalate dose in good responders by imaging using rule-based imaging-response guided omission of 2nd "pulse" of PULSAR fractionated SRS (fSRS) for brain metastases
Time frame: 5 years
Sample size comparing local control \& toxicity with prior PULSAR data(which didn't dose de-escalate based on response)to ensure high control rate is preserved.Using two-tailed test with alpha of 0.05 \& power of 0.8,estimated sample size to detect difference in 1-yr local failure rates between pSRT \& fSRT.Stats according to variable type(continuous,categorical)used for reporting primary endpoint of proportion of patients de-escalated \& endpoints.To evaluate local control \& toxicity(late CNS),competing risk regression \& calculated cumulative incidence,with death as competing risk will be performed.Gray's test will be used to assess statistical significance.OS analyzed using Kaplan-Meier method using survival,log-rank test employed to compare survival distributions.To account for clustered data,where patients may have multiple brain metastases treated,repeated analyses for CRR using crrSC(R package)will be performed.
COHORT C- assess the rate of MWC in a novel approach of immunotherapy with concurrent PULSAR.
Time frame: 5 years
Descriptive analyses will summarize the number and proportion of patients with MWCs, exact 95% confidence intervals, timing of MWCs relative to surgery, severity, management required, attribution to treatment, and whether each event occurred within the irradiated field. Given the small sample size and feasibility-oriented objective, analyses will be primarily descriptive rather than powered for formal hypothesis testing. Exploratory outcomes, including progression-free survival, pathologic response, immune correlates, and other clinical endpoints, will be summarized descriptively to inform future study design.
COHORT D-assess the proportion of patients who proceed to curative intent resection following neoadjuvant therapy.
Time frame: 5 years
The primary endpoint is feasibility of the neoadjuvant radiotherapy and immunotherapy paradigm, defined as the proportion of patients who proceed to curative-intent surgical resection. Feasibility will be evaluated separately for each treatment arm, with particular focus on the PULSAR-IO arm. For each arm, the observed proportion proceeding to surgery will be summarized along with Exact (Clopper-Pearson) binomial confidence intervals. Feasibility will be declared if at least 90% of patients in the treatment arm proceed to curative-intent surgery. No formal hypothesis testing or between-arm comparisons are planned for the primary feasibility endpoint.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \>=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 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
Where
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
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Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations