Photon Craniospinal Irradiation for Breast and Lung Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: Neurologic symptoms, Uncontrolled disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new type of radiation therapy, photon craniospinal irradiation (CSI), for individuals with breast or non-small cell lung cancer that has spread to the brain and spinal fluid (leptomeningeal disease). The treatment uses high-energy x-rays to target cancer cells in the brain and spinal cord. The trial seeks participants with breast cancer or non-small cell lung cancer with leptomeningeal disease who can read and understand English or Spanish. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to important research.

Will I have to stop taking my current medications?

The trial requires that you stop chemotherapy, biological therapy, or immunotherapy at least 7 days before starting the study treatment. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

What prior data suggests that photon craniospinal irradiation is safe for treating leptomeningeal disease in breast and lung cancer patients?

Research has shown that proton craniospinal irradiation (pCSI), similar to photon craniospinal irradiation (CSI), was well-tolerated in past studies. Patients demonstrated better survival rates with manageable side effects. Although photon-VMAT-CSI is not identical, these results suggest it might also be safe for treating leptomeningeal disease, which occurs when cancer spreads to the lining of the brain and spinal cord from breast or lung cancer. Phase 2 trials primarily assess treatment safety, indicating that photon-VMAT-CSI is considered reasonably safe for human testing. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for breast and lung cancer, which often involve traditional radiation methods targeting specific tumor areas, photon craniospinal irradiation (CSI) is unique because it delivers radiation across the entire craniospinal axis. This approach is designed to potentially reduce the risk of cancer spreading to the brain and spine, which can be a concern with these cancers. Researchers are excited about this treatment because it uses advanced photon-VMAT (Volumetric Modulated Arc Therapy) technology to precisely target the entire region, aiming to minimize exposure to healthy tissues and reduce side effects during treatment.

What evidence suggests that Photon Craniospinal Irradiation might be an effective treatment for leptomeningeal disease?

Research has shown that photon craniospinal irradiation (CSI) is a promising treatment for cancer that spreads to the fluid and protective layers around the brain and spinal cord, often due to breast cancer or non-small cell lung cancer (NSCLC). This trial will evaluate the effectiveness of photon-VMAT-CSI, which uses focused radiation to target and destroy cancer cells in these areas. Studies have found that CSI can effectively treat solid tumors in this space, potentially improving survival rates. Photon CSI addresses cancer spread in these critical areas, offering hope for those affected. ^{1 3 6 7 8}

Who Is on the Research Team?

Stephanie M Yoon

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread to the cerebrospinal fluid and meninges. Participants must have a life expectancy of more than 3 months, be able to undergo MRI scans, and provide informed consent. Those with certain medical conditions or who are pregnant cannot join.

Inclusion Criteria

Absolute neutrophil count (ANC) ≥ 1,000/mm^3

Hemoglobin ≥ 8 g/dL

Platelet count ≥ 100,000/mm^3

Exclusion Criteria

Pregnant or breastfeeding females

Other clinically significant uncontrolled illness per opinion of physician/investigator

History or evidence of hepatitis C virus (HCV) infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Radiation Treatment

Participants undergo photon-VMAT-CSI once daily for 10 treatments over 10-20 days

2-4 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI and CSF sample collection

1 year

1 visit at 1 month, then every 3 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Photon Craniospinal Irradiation

Trial Overview The study tests photon craniospinal irradiation using volumetric modulated arc radiotherapy (VMAT) on patients whose breast cancer or NSCLC has spread to brain/spinal cord coverings. It aims to see if this targeted radiation therapy can effectively kill tumor cells in these areas.

How Is the Trial Designed?

Group I: Treatment (Photon-VMAT-CSI) Experimental Treatment 8 Interventions

Patients undergo photon-VMAT-CSI QD for 10 treatments over 10-20 days (Monday-Friday) in the absence of disease progression or unacceptable toxicity. Patients undergo MRI during screening and follow-up and undergo collection of blood samples throughout the trial. Patients also undergo LP or Ommaya reservoir tap for CSF sample collection during screening and follow-up.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of six female pediatric patients, craniospinal irradiation (CSI) using proton beam therapy resulted in minimal radiation exposure to breast tissue, with average doses near zero, suggesting a lower risk for secondary breast cancer.

In contrast, CSI using x-ray therapy delivered significant radiation doses to the breast, with average maximum doses of 23 Gy, indicating that early breast cancer screening may be necessary for patients treated with x-ray therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer screening for childhood cancer survivors after craniospinal irradiation with protons versus x-rays: a dosimetric analysis and review of the literature. Kumar, RJ., Zhai, H., Both, S., et al.[2022]

In a study of 38 pediatric patients treated with either vertebral body-sparing proton craniospinal irradiation (VBSpCSI) or traditional photon-based craniospinal radiotherapy (3DCRT), VBSpCSI was associated with significantly lower rates of acute gastrointestinal toxicity and nausea, indicating a safer profile for young patients.

Patients receiving VBSpCSI also experienced fewer severe hematologic toxicities, such as lower rates of red blood cell transfusions and lymphopenia, suggesting that this technique may reduce treatment-related side effects compared to conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumetric de-escalation and improved acute toxicity with proton craniospinal irradiation using a vertebral body-sparing technique. Chou, B., Hopper, A., Elster, J., et al.[2022]

In a study comparing proton beam craniospinal irradiation (PrBCSI) to conventional photon beam CSI (PhBCSI) in children with brain tumors, PrBCSI resulted in significantly less severe thrombocytopenia and no reported cases of diarrhea, indicating a better safety profile.

Patients receiving PrBCSI showed improved recovery rates for leukocyte and platelet counts one month after treatment compared to those receiving PhBCSI, suggesting enhanced efficacy in managing treatment-related blood cell reductions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam therapy reduces the incidence of acute haematological and gastrointestinal toxicities associated with craniospinal irradiation in pediatric brain tumors. Song, S., Park, HJ., Yoon, JH., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06910761

NCT06910761 | Photon Craniospinal Irradiation for the ... Photon-VMAT-CSI may be an effective treatment option for patients with leptomeningeal disease secondary to breast cancer or NSCLC. Detailed Description. PRIMARY ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-02015

Photon Craniospinal Irradiation for the Treatment of ... Photon-VMAT-CSI may be an effective treatment option for patients with leptomeningeal disease secondary to breast cancer or NSCLC. Eligibility Criteria ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625059012

1067 Toxicity and Clinical Outcomes of Proton vs. Photon ... Craniospinal irradiation (CSI) is an effective treatment for solid tumor leptomeningeal carcinomatosis (LMC). Although proton CSI (pCSI) improves survival vs ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12016269/

Early experience with proton craniospinal irradiation in adult ... Recent data from a randomized phase II trial comparing pCSI to IFRT in 63 patients with LMD from either breast cancer or non-small cell lung ...

5. redjournal.org redjournal.org/article/S0360-3016(25)02711-7/fulltext

Toxicity Comparison of Photon and Proton Craniospinal ... Proton craniospinal irradiation (pCSI) improved overall survival (OS) for patients with leptomeningeal metastases (LM) from breast and lung cancer in a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11758840/

Early Outcomes from Proton Craniospinal Irradiation for ... A recent phase 2 study found that proton craniospinal irradiation (pCSI) was well-tolerated and improved survival. We report our experience with pCSI for solid ...

7. jamanetwork.com jamanetwork.com/journals/jamaoncology/article-abstract/2838532

Proton Craniospinal Irradiation for Patients With ... This randomized clinical trial examines proton craniospinal irradiation compared with involved-field radiotherapy in improving superior ...

8. ascopost.com ascopost.com/news/september-2025/proton-craniospinal-irradiation-for-leptomeningeal-metastasis-in-lung-or-breast-cancer/

Proton Craniospinal Irradiation for Leptomeningeal ... In the U.S. multicenter open-label trial, 63 patients (57% with NSCLC and 43% with breast cancer in each group) were randomly assigned 2:1 ...