RecruitingPhase 2

Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial

Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial (ACTION-Brain Metastases: Pilot Pragmatic Trial)

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

  • Time periods mentioned: 2 years
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All patients will undergo a re-evaluation brain MRI 4-8 weeks after initiating systemic therapy."
  • "Patients will undergo a re-evaluation MRI 4-8 weeks after starting systemic therapy."
  • "If metastases are stable or regressing, radiation will be deferred and the patient will enter a structured surveillance protocol with MRIs every 3 months for up to 2 years."
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 people with cancer that has spread to the brain can avoid brain radiation when cancer medicines control the tumors. It is for adults with non-small cell lung cancer or other solid tumors. A brain MRI 4–8 weeks after starting medicine will help doctors decide whether to keep watching the tumors or consider radiation.

This pilot pragmatic trial evaluates the feasibility of avoiding radiation therapy in patients with brain metastases who demonstrate an intracranial response to systemic therapy-including immunotherapy, targeted therapy, and/or chemotherapy. The study will prospectively enroll 45 patients, divided into two cohorts: 30 with non-small cell lung cancer (NSCLC) receiving immunotherapy, and 15 with brain metastases from other solid tumors. Eligible participants must have at least one brain metastasis not planned for radiation or surgery and must be initiating or planning to initiate a systemic therapy regimen expected to penetrate the blood-brain barrier and achieve intracranial activity. All patients will undergo a re-evaluation brain MRI 4-8 weeks after initiating systemic therapy. If lesions are stable or regressing, patients will continue surveillance without radiation. If progression is noted, standard-of-care radiation may be administered at the discretion of the treating physician. The primary objective is to assess 6-month radiation therapy-free survival (RTFS) in NSCLC patients based on PD-L1 expression status. Secondary endpoints include intracranial progression-free survival, overall survival, radiation necrosis rate, and quality of life. This study seeks to inform future trial design and identify patients who may safely avoid brain radiation.

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

Eligibility

Who can join

  • Be age 18 or older.
  • Have a solid tumor cancer confirmed by tissue or cell testing within 5 years. If testing was earlier, newer testing or clear scans showing cancer spread outside the brain are needed.
  • Be starting or planning cancer medicine expected to work in the brain, such as targeted drugs, immune treatments, or certain breast cancer treatments. Chemotherapy alone is allowed at first only if an eligible targeted or immune treatment is planned before the follow-up MRI.
  • Start cancer medicine within 4 weeks before or after the brain MRI showing new or growing cancer.
  • Have at least one brain tumor that is not planned for radiation or surgery. All brain tumors not planned for surgery must be 3 centimeters or smaller.
  • Be able to have brain MRI scans with contrast dye and very thin images, no more than 1.5 millimeters thick.
  • Have a Karnofsky Performance Status score above 60, a measure of how well you can do daily tasks and care for yourself.
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • The planned new cancer medicine must not have been used to treat brain tumors in the past 6 months.
  • Have had radiation to the active brain tumors, including radiation to part or all of the brain or radiation meant to prevent brain spread.
  • Be pregnant or breastfeeding. People who could become pregnant need a negative urine pregnancy test within 14 days before signing up.
  • Have a serious health problem that the study doctor believes would prevent participation.
  • Have known leptomeningeal disease, which means cancer has spread to the layers covering the brain and spinal cord.

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

Official eligibility criteria

Inclusion Criteria: Pathologically (histologically or cytologically) proven diagnosis of a solid tumor malignancies within 5 years prior to registration. If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, PET/CT, etc.) is required. These scans are considered standard-of-care (SOC) and will not be ordered for research purposes. Initiation or planning for initiation of systemic therapy to include one or more of the following categories expected to cause an intracranial response: * Brain penetrant targeted therapies (e.g. tyrosine kinase inhibitors, multikinase inhibitors, EGFR inhibitor, ALK inhibitor, BRAF/MEK inhibitor) * Checkpoint inhibitor immunotherapy (e.g. PDL-1 inhibitors, PD1 inhibitors, CTLA-4 inhibitors) * HER2 antibody-drug conjugate (e.g. TDM1, TDX-D) * Anti-Hormone therapies for Breast Cancer * Cytotoxic chemotherapy alone may be started initially, but with plan for immunotherapy or eligible targeted therapy noted above before the re-evaluation MRI head At least 1 brain metastasis that not planned for radiation therapy or surgery. All brain metastases not planned for resection much be ≤3 cm, with no minimum size required. Systemic therapy has started within 4 weeks of MRI brain showing new or progressive disease or plan to start systemic therapy within 4 weeks of MRI brain showing new or progressive disease. Ability to obtain MRI head scans with contrast. All MRI head scans must have slice thickness ≤1.5 mm. Age ≥ 18 years KPS \>60 Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: No use of the planned new systemic therapy meeting 2.1.2 criteria to address brain metastases within the last 6 months. Prior radiotherapy to the active brain metastases (partial or whole brain irradiation, or prophylactic cranial irradiation \[PCI\]) Patients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. Negative urine pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Serious medical comorbidities that in the opinion of the investigator would prevent participation in this study. Known leptomeningeal disease (LMD) \-

Study sites (1)

VT