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โ† Trials
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Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)

RecruitingPhase 1Ages 18 Years - anyAllUniversity of Texas Southwestern Medical Center
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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: โจ€ 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
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What it tests

  • 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
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Where

1 site
Ut Southwestern Medical Center
Dallas, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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