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RecruitingPhase 1

Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)

Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether radiation treatment can be safely adjusted based on how each person responds, and whether it may help. It is for people with certain lung cancers, cancers that have spread to the brain, soft tissue cancers, or head and neck cancers.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Groups A, C, and D: Age 18 or older and able to care for yourself and be up for more than half the day.
  • Group A: Small cell lung cancer that has spread widely, confirmed by a tissue sample within 180 days before signing up.
  • Group A: Planning to start or already getting standard chemotherapy plus immunotherapy, which helps the immune system fight cancer. You must have had no more than 3 treatment cycles and be able to receive chest radiation.
  • Group B: The listing states age 18. You must have a solid tumor cancer that has spread to the brain, seen on MRI within 60 days before signing up. Each brain tumor included must measure 2–5 cm, or 1.5–5 cm if in the brainstem.
  • Group C: Soft tissue sarcoma, a cancer in tissues such as muscle or fat, confirmed by a tissue sample. It must be grade 2 or 3, meaning faster-growing, in the torso, arms, or legs, and larger than 5 cm on a scan.
  • Group C: The cancer must not have spread and must be removable with surgery. You must be able to receive immunotherapy.
  • Group D: Squamous cell cancer confirmed by a tissue sample in the mouth, throat, or voice box. It must be stage III or IVA.
  • Group D: A head and neck surgeon must judge that surgery can remove the cancer. You must be able to receive immunotherapy.

Who can't join

  • Group A: Past radiation to the chest.
  • Group B: Past radiation to the whole brain, or past surgery or focused radiation for a brain tumor being studied.
  • Group B: Cancer in the tissue and fluid around the brain and spinal cord.
  • Group C: Cancer that cannot be removed by surgery, has spread to lymph nodes or elsewhere, or has returned in the same area.
  • Group C: Another current cancer needing chemotherapy or other intensive treatment, past immunotherapy, pregnancy, or breastfeeding.
  • Group D: Cancer that has spread to distant parts of the body, or inability to have a PET-CT scan to check its spread before treatment.
  • Group D: Cancer in the middle part of the throat that tests positive for HPV or p16.
  • Group D: Past chemotherapy for this cancer, any past immunotherapy, or past head and neck radiation. Past chemotherapy for an earlier cancer is allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

TX