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Sponsor: University of Texas Southwestern Medical Center
Conditions: Small Cell Lung Cancer Extensive Stage, Brain Metastases, Solid Tumor, Adult, Thoracic Cancer, Sarcoma,Soft Tissue
Interventions: 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 PULSAR, Cohort D: Resectable Head & Neck Squamous Cell Carcinoma (HNSCC) PULSAR/SAbR
Countries: United States
To characterize feasibility, safety, and/or preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Dallas, Texas, United States