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New treatment option for Anatomic Stage IV Breast Cancer AJCC v8
Official title Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06910761
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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 multiple or serious major neurologic symptoms (including encephalopathy) per physician / investigator assessment
- Patients with extensive, uncontrolled extracranial systemic disease
- Patients without reasonable systemic treatment options per physician / investigator
- Other clinically significant uncontrolled illness per opinion of physician / investigator
See the full eligibility criteria
- 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...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
- 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 multiple or serious major neurologic symptoms (including encephalopathy) per physician / investigator assessment
- Patients with extensive, uncontrolled extracranial systemic disease
- Patients without reasonable systemic treatment options per physician / investigator
- Other clinically significant uncontrolled illness per opinion of physician / investigator
- 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...
- 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 how well it works assessment of the study are...
- Females only: Pregnant or breastfeeding
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.