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

ConditionsAnatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Neoplasm in the LeptomeningesStage IV Lung Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and CSF sample collection

  • Craniospinal Irradiation

    Radiation

    Undergo photon-VMAT-CSI

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Lumbar Puncture

    Procedure/Surgery

    Undergo LP

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Ommaya Reservoir Tap

    Procedure/Surgery

    Undergo Ommaya reservoir tap

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Volume Modulated Arc Therapy

    Radiation

    Undergo photon-VMAT-CSI

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Treatment (Photon-VMAT-CSI)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Central nervous system (CNS)-progression free survival

Will be estimated using the Kaplan-Meier estimator, and its associating 95% confidence limit will be calculated using the logit transformation and the Greenwood variance estimate.

Time frame
From start of treatment to CNS relapse, CNS progression, death (from any cause), or last contact, whichever occurs first, assessed up to 1 year

Secondary outcomes

1

Radiographic response

Will be assessed per European Organization for Research and Treatment of Cancer (EORTC) Response Assessment in Neuro-Oncology. Will be characterized using a (generalized) linear mixed effects model.

Time frame
Every 3 months after treatment until CNS disease progression or death, assessed up to 1 year
2

Quality of life

Will be assessed per EORTC Quality-of-Life Questionnaire Brain 20, EORTC Core Quality-of-Life Questionnaire 30, Patient Reported Outcome Measurement Information System (PROMIS) Anxiety short form and PROMIS Cognition short form. Will be characterized using a (generalized) linear mixed effects model.

Time frame
At baseline, 1 month, and every 3 months until CNS disease progression or death, assessed up to 1 year
3

Incidence of adverse events

Will be assessed and graded according to the Common Terminology Criteria for Adverse Events version 5.0. Will be tabulated to show the number and percentage as well as the timing, severity, and attribution of the toxicity.

Time frame
Up to 30 days after the last day of treatment
4

Overall survival

Will be estimated using the Kaplan-Meier estimator, and its associating 95% confidence limit will be calculated using the logit transformation and the Greenwood variance estimate.

Time frame
From start of treatment to death (from any cause), or last contact, whichever occurs first, assessed up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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