BRain-AVOidant Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumor Malignancies

Browse trials for

• Meningeal Carcinomatosis 119
• Breast Neoplasms 12,513
• Lung Neoplasms 7,232
• Carcinoma, Non-Small-Cell Lung 6,472

Keywords

• breast cancer
• lung cancer
• leptomeningeal metastasis
• craniospinal irradiation

Study arms

• Experimental
  Radiation Treatment

  Participants in this group will undergo radiation treatments using brain-avoidant proton craniospinal irradiation (CSI). The prescribed radiation dose for all participants will be 30Gy (Cobalt Gray Equivalent \[CGE\]) in 10 fractions.

  Radiation: Radiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI)

• No intervention
  Non-Interventional Arm

  Participants who decline BRAVO-pCSI will have the option to enroll in a non-interventional exploratory arm. Participants in this group will undergo the same baseline and follow-up assessments as participants receiving BRAVO-pCSI, including radiographic evaluations, cerebrospinal fluid (CSF) and serum assessments, neurocognitive testing, and quality-of-life assessments. No study intervention will be administered.

Interventions

• RadiationRadiation Treatments Using Brain- Avoidant Proton Craniospinal Irradiation (BRAVO- pCSI)

  Participants with Leptomeningeal Metastases (LM) from breast or non-small cell lung cancer will be included in Group 1 (20 evaluable participants). Participants with LM from solid tumors of other histologies will be included in Group 2 (10 evaluable participants). All participants in Groups 1 and 2 will receive Brain-Avoidant Proton Craniospinal Irradiation (BRAVO-pCSI) at a prescribed dose of 30 Gy (Cobalt Gray Equivalent \[CGE\]) delivered in 10 fractions. Protocol treatment must begin within 21 days of study enrollment and will be delivered over approximately 2 weeks.

Primary outcomes

1. Central Nervous System Progression Free Survival (CNS PFS)

   Central Nervous System Progression Free Survival (CNS PFS) is defined as the elapsed time from start of brain-avoidant pCSI until the date of first event of CNS disease progression or death.

   Time frame: Up to 1.5 years

Secondary outcomes

1. Overall Survival (OS) after brain-avoidant pCSI

   Overall Survival (OS) is defined as the elapsed time from start of brain-avoidant pCSI until date of death from any cause.

   Time frame: Up to 1.5 years

2. Treatment Response Rate After Brain-Avoidant Proton Craniospinal Irradiation (BRAVO-pCSI)

   Response rate is defined as the proportion of participants showing best responses per Response Assessment in Neuro-Oncology Leptomeningeal Metastases (RANO LM) criteria.

   Time frame: Up to 1.5 years

3. Evaluation of the Safety And Tolerability of Brain-Avoidant Proton Craniospinal Irradiation (BRAVO-pCSI)

   Incidence of adverse events (AEs) and serious adverse events (SAEs) related to brain-avoidant pCSI, as assessed using the NCI CTCAE Version 5.0.

   Time frame: Up to 1.5 years

4. Rate of Cognitive Failure After Brain-Avoidant Proton Craniospinal Irradiation (BRAVO-pCSI)

   Cognitive failure measured via the reliable change index (RCI) after BRAVO pCSI.

   Time frame: 3 months

5. Patient-Reported Depression

   Depression will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). Total scores range from 0 to 60, with higher scores indicating greater depressive symptoms.

   Time frame: Up to 1.5 years

6. Patient-Reported Fatigue

   Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Subscale Version 4 (Items 1-13). Total scores range from from 0 to 52, with higher scores indicating less fatigue.

   Time frame: Up to 1.5 years

7. Mean Symptom Severity Score (MDASI-BT)

   Mean score on the symptom severity subscale of the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT). Scores range from 0 to 10, with higher scores indicating greater symptom severity.

   Time frame: Up to 1.5 years

8. Mean Disease-Specific Symptom Score (MDASI-BT)

   Mean score on the brain tumor-specific symptom subscale of the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT). Scores range from 0 to 10, with higher scores indicating greater symptom burden.

   Time frame: Up to 1.5 years

9. Mean Symptom Interference Score (MDASI-BT)

   Mean score on the symptom interference subscale of the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT). Scores range from 0 to 10, with higher scores indicating greater symptom interference.

   Time frame: Up to 1.5 years

10. Mean Symptom Severity Score (MDASI-SP)

    Mean score on the symptom severity subscale of the MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP). Scores range from 0 to 10, with higher scores indicating greater symptom severity.

    Time frame: Up to 1.5 years

11. Mean Disease-Specific Symptom Score (MDASI-SP)

    Mean score on the spine tumor-specific symptom subscale of the MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP). Scores range from 0 to 10, with higher scores indicating greater symptom burden

    Time frame: Up to 1.5 years

12. Mean Symptom Interference Score (MDASI-SP)

    Mean score on the symptom interference subscale of the MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP). Scores range from 0 to 10, with higher scores indicating greater symptom interference.

    Time frame: Up to 1.5 years

Individual participant data

Plan to share: No