Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)
Recruiting · NCT07139990 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Cohort A: Extensive Stage Small Cell Lung Cancer (ES-SCLC) Thoracic Tumor PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)Cohort B: Brain metastasis PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)Cohort C: Sarcoma Pre-Operative PULSARCohort D: Resectable Head & Neck Squamous Cell Carcinoma (HNSCC) PULSAR/SAbR
What this trial is about
To characterize feasibility, safety, and/or preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Ut Southwestern Medical Center - Dallas, Texas, United States