RECRUITING

Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial

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Conditions

Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Neoplasm in the LeptomeningesStage IV Lung Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase III trial compares proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis). Patients with leptomeningeal metastasis (LM) may develop multiple areas of nervous system (neurologic) impairment that can be life-threatening. Radiation therapy (RT) effectively relieves local symptoms due to LM. RT uses high energy radiography (x-rays), particles, or radioactive seeds to kill cancer cells and shrink tumors. IFRT is commonly used to treat symptoms of LM. IFRT is radiation treatment that uses x-rays to treat specific areas of LM and to relieve and/or prevent symptoms. pCSI uses protons that can be directed with more accuracy than x-rays which allows treatment of the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord. The pCSI treatment could delay the worsening of LM. Giving pCSI may be better than IFRT in treating LM in patients with breast or non-small cell lung cancer.

Official Title

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)

Quick Facts

Study Start:2024-11-21
Study Completion:2033-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06500481

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PRIOR TO STEP 1 REGISTRATION
  2. * Patients with pathologically (histologically or cytologically) proven diagnosis of breast cancer or NSCLC. Patients must have systemic disease evaluation through standard of care imaging for example CT chest/abdomen/pelvis or body PET/CT
  3. * Patients must have newly diagnosed leptomeningeal metastasis established through at least one of the following:
  4. * Positive CSF cytology for malignancy
  5. * CSF cytology with suspicious cells is considered positive; CSF cytology with atypical cells is considered equivocal and not positive
  6. * Patients with an equivocal CSF cytology result, or not suitable for CSF sampling, radiographic diagnosis of leptomeningeal metastasis with linear and/or nodular disease and documentation of typical clinical signs (European Association of Neuro-Oncology \[EANO\]-European Society for Medical Oncology \[ESMO\] Diagnostic Criteria Type IIA-IIC) is required
  7. * Patients with typical clinical signs of leptomeningeal metastasis may have one or more of the following symptoms and signs: headache, nausea, vomiting, mental status change, gait difficulty, cranial nerve palsy, diplopia, visual change, hearing loss, radicular weakness, radicular sensory change, urinary retention, saddle anesthesia, constipation, neck pain, and back pain
  8. * For patients with prior history of immunotherapy or current immunotherapy, CSF sampling rather than just MRI enhancement is strongly recommended to exclude immune-related aseptic meningitis
  9. * Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastasis
  10. * Age ≥ 18
  11. * PRIOR TO STEP 2 REGISTRATION
  12. * Note: Step 2 registration must occur no later than 30 calendar days after step 1 registration
  13. * Financial clearance for proton therapy treatment
  14. * Karnofsky performance status ≥ 60
  15. * Not pregnant and not nursing
  16. * Negative urine or serum 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
  17. * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8.0 g/dl is acceptable)
  18. * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 (Note: the use of granulocyte-colony stimulating factor or other intervention to achieve ANC ≥ 1,000/mm\^3 is acceptable)
  19. * Platelets ≥ 100,000/mm\^3 (Note: the use of transfusion or other intervention to achieve platelets ≥ 100,000/mm\^3 is acceptable)
  20. * Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (patients with known Gilbert disease without other clinically significant liver abnormalities are not excluded)
  21. * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine transaminase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × ULN
  22. * No prior radiation therapy to the spinal cord with equivalent dose in 2 gray (Gy) fractions (EQD2) more than 40Gy or cauda equina with EQD2 more than 50Gy using alpha/beta ratio of 3
  23. * No prior treatment for leptomeningeal metastasis (note: prior CNS treatment for other non-leptomeningeal disease is allowed)
  24. * No history of unstable angina requiring hospitalization in the last 3 months
  25. * No history of myocardial infarction within the last 3 months
  26. * New York Heart Association Functional Classification II or better (New York Heart Association \[NYHA\] Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
  27. * No active infection currently requiring intravenous (IV) antibiotic management
  28. * No active chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy
  29. * No CTCAE v5.0 ≥ grade 2 encephalopathy
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jonathan Yang
CONTACT
(212) 731-6033
jonathan.yang@nyulangone.org

Principal Investigator

Jonathan T Yang
PRINCIPAL_INVESTIGATOR
NRG

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
UC San Diego Health System - Encinitas
Encinitas, California, 92024
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
United States
Mercy Hospital South
Saint Louis, Missouri, 63128
United States
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
United States
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NRG Oncology

  • Jonathan T Yang, PRINCIPAL_INVESTIGATOR, NRG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-21
Study Completion Date2033-07-31

Study Record Updates

Study Start Date2024-11-21
Study Completion Date2033-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Breast Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Malignant Neoplasm in the Leptomeninges
  • Stage IV Lung Cancer AJCC v8