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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Photon Craniospinal Irradiation for breast and lung cancer?

Photon therapy, when combined with other radiation types like electrons, has been shown to improve dose distribution and reduce side effects in breast cancer treatment, as seen in studies involving post-mastectomy irradiation. Additionally, photon-based techniques have been effective in targeting specific areas, such as the tumor bed in breast cancer, suggesting potential benefits for craniospinal irradiation. ^{1 2 3 4 5}

Is photon craniospinal irradiation generally safe for humans?

Photon craniospinal irradiation has been studied in children, and it can cause acute side effects like blood and stomach issues, but these effects are generally manageable. Techniques like vertebral body-sparing can reduce some of these side effects, suggesting that safety can be improved with advanced methods. ^{6 7 8 9 10}

How does Photon Craniospinal Irradiation differ from other treatments for breast and lung cancer?

Photon Craniospinal Irradiation is unique because it involves targeting the entire craniospinal axis with radiation, which is not a standard approach for breast and lung cancer. This method is typically used to prevent or treat metastases (spread of cancer) to the brain and spinal cord, which is more common in cancers like small cell lung cancer, but not typically in breast and non-small cell lung cancer. ^{11 12 13 14 15}

Research Team

Stephanie M Yoon

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Single-fraction radiosurgery for the treatment of spinal breast metastases. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A blended beam technique to decrease toxic effects of post mastectomy irradiation by combining and sequentially mixing electrons and photons. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Field match verification during combination proton, photon, and electron therapy for oligometastatic inflammatory breast cancer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Targeted intra-operative radiotherapy (Targit): an innovative method of treatment for early breast cancer. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of photon versus electron for tumor bed boost radiotherapy post-breast conserving surgery. [2023]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Volumetric de-escalation and improved acute toxicity with proton craniospinal irradiation using a vertebral body-sparing technique. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Craniospinal irradiation techniques: a dosimetric comparison of proton beams with standard and advanced photon radiotherapy. [2022]

9. England 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Acute toxicity and treatment interruption related to electron and photon craniospinal irradiation in pediatric patients treated at the University of Texas M. D. Anderson Cancer Center. [2019]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Prophylactic brain irradiation and radiotherapy of brain metastases of small cell lung cancer]. [2006]

12. United States pubmed.ncbi.nlm.nih.gov

The role of radiation therapy for carcinoma of the lung. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

Prophylactic cranial irradiation could improve overall survival in patients with extensive small cell lung cancer : A retrospective study. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Prophylactic cranial irradiation in the treatment of small-cell carcinoma of the lung. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Radiotherapy for small cell lung cancer. [2019]