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NCT06910761RecruitingPhase 2

Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer

Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy

Source: ClinicalTrials.gov · Last updated 8 Dec 2025

Brief summary (registry, in English)

This phase II trial tests how well craniospinal irradiation (CSI) using photon volumetric modulated arc radiotherapy (VMAT) works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal disease). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. Photon-VMAT-CSI may be an effective treatment option for patients with leptomeningeal disease secondary to breast cancer or NSCLC.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
35 (estimated)
First submitted
28 Mar 2025
Start date
5 May 2025
Primary completion date
2 Oct 2028
Lead sponsor
City of Hope Medical Center
NCT number
NCT06910761

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 35
  • From 5 May 2025 to the primary completion date, 2 Oct 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Chemotherapy, biological therapy, immunotherapy within 7 days prior to day 1 of protocol therapy
  • Any prior radiation that in the opinion of the investigator unable to respect normal tissue tolerances and preclude craniospinal irradiation
  • Patients with a history or evidence of HIV infection (unless on effective anti-retroviral therapy with undetectable viral load based on prior tests within 6 months are eligible for this trial)
  • Patients with history or evidence of chronic hepatitis B virus (HBV) infection (unless HBV viral load is undetectable based on prior tests and on suppressive therapy)
  • Patients with a history or evidence of hepatitis C virus (HCV) infection unless treated and cured. (Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load based on prior tests)
  • Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study are eligible for this trial

Other illness

  • Patients with extensive, uncontrolled extracranial systemic disease
  • Other clinically significant uncontrolled illness per opinion of physician / investigator
  • Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Other

  • Patients with multiple or serious major neurologic symptoms (including encephalopathy) per physician / investigator assessment
  • Patients without reasonable systemic treatment options per physician / investigator
  • Females only: Pregnant or breastfeeding
  • Unable to undergo MRI brain and spine with gadolinium contrast
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Who the study is looking for

  • Documented informed consent of the participant and/or legally authorized representative
    • Assent, when appropriate, will be obtained per institutional guidelines
  • ≥ 18 years
  • Karnofsky performance status (KPS) ≥ 60
  • Ability to read and understand English or Spanish for questionnaires, or ability to complete questionnaires using certified interpreter
  • Histologically confirmed breast cancer or non-small cell lung cancer
  • Leptomeningeal disease established either radiographically and/or CSF cytology
  • Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
  • Hemoglobin ≥ 8 g/dL
  • Platelet ≥ 100,000/mm\^3
  • Creatinine clearance of ≥ 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
    • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy
    • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
City of Hope Medical Center
Coordinator of this site? Confirm its status
DuarteUnited StatesRecruiting
City of Hope at Irvine Lennar
Coordinator of this site? Confirm its status
IrvineUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.