~9 spots leftby Dec 2026

Proton Radiotherapy for Palliative Cancer Care

Recruiting in Palo Alto (17 mi)
AA
Overseen byAnthony Apicelli, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Washington University School of Medicine
Must not be taking: Cytotoxic, VEGF inhibitors
Disqualifiers: Urgent surgery, Superficial lesions, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Spatially fractionated radiotherapy (SFRT or GRID) addresses some limitations of traditional stereotactic body radiation therapy by relying on beam collimation to create high-dose "peaks" and intervening low-dose "valleys" throughout the target volume. Standard palliative radiotherapy regimens provide limited durability of response, and there are challenges with delivery to large tumors or in previously irradiated fields. In this study, Proton GRID radiotherapy will be used to deliver three-fraction palliative radiotherapy to patients with tumors needing palliative radiation. The safety and efficacy of this approach will be assessed. It is hypothesized that GRID is highly effective, immunogenic, and associated with low rates of toxicity.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, if you are currently receiving cytotoxic cancer therapy or VEGF inhibitors, you cannot take them at the same time as the proton GRID treatment. A 2-week break from these medications is recommended but not required before starting the trial.

What data supports the effectiveness of Proton GRID Radiotherapy for palliative cancer care?

Research shows that palliative radiotherapy, including advanced techniques like Proton GRID Radiotherapy, is effective in relieving symptoms for patients with advanced cancer. It is a time-efficient treatment that can provide symptom relief with minimal side effects, making it a valuable option for improving quality of life in palliative care.12345

Is proton radiotherapy safe for palliative cancer care?

Research on spatially fractionated radiotherapy (GRID) and its variations, including proton GRID therapy, suggests it is generally safe for treating large tumors, with studies reporting good safety profiles in patients. However, the understanding of its effects is still developing, and it is used in limited centers.678910

How is Proton GRID Radiotherapy different from other cancer treatments?

Proton GRID Radiotherapy is unique because it uses a spatially fractionated approach, delivering high doses of radiation in a grid pattern, which helps protect healthy tissue while targeting large tumors. This method combines the precision of proton therapy with the benefits of GRID therapy, making it suitable for treating tumors near critical organs with reduced toxicity.911121314

Research Team

AA

Anthony Apicelli, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults with confirmed cancer who need palliative radiation for large tumors or previously irradiated lesions. Participants must agree to use contraception and have an ECOG performance status ≤ 3. Excluded are those needing urgent surgery, pregnant women, patients on certain cancer therapies overlapping with the trial, and HIV-positive individuals with low CD4+ counts or recent opportunistic infections.

Inclusion Criteria

Histologically or cytologically confirmed cancer diagnosis
I am in a group of 10 patients with previously irradiated lesions.
I am planning to have radiotherapy for a large, inoperable cancer lesion.
See 5 more

Exclusion Criteria

Patients with HIV and CD4+ T-cell counts < 350 cells/mcL or history of AIDS-defining opportunistic infection within the 12 months prior to registration
I am not on any cancer treatments that would interfere with proton GRID therapy.
My tumor requires immediate surgery.
See 2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 20 Gy proton GRID radiotherapy in 3 fractions for palliative treatment

1 week
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Visits at 2 weeks, 30 days, 90 days, 180 days, and 360 days

Treatment Details

Interventions

  • Proton GRID Radiotherapy (Proton Beam Therapy)
Trial OverviewThe study tests Proton GRID Radiotherapy as a three-fraction palliative treatment for cancerous tumors. It aims to see if this method, which creates high-dose areas within the tumor while sparing surrounding tissue, is safe and effective compared to traditional radiotherapy.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort B: De Novo Radiation Treatment FieldsExperimental Treatment1 Intervention
Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.
Group II: Cohort A: Reirradiation of Treatment FieldsExperimental Treatment1 Intervention
Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2027
Patients Recruited
2,353,000+

Findings from Research

Advancing the Role of Proton Therapy for Spine Metastases Through Diagnostic Scan-Based Planning.Swanick, CW., Shang, MH., Erhart, K., et al.[2023]
Single dose radiotherapy in soft tissue tumoral masses: just enough palliation.Vargas, A.[2022]
Palliative radiotherapy: current status and future directions.Sharma, S., Hertan, L., Jones, J.[2022]
Palliative radiotherapy trials for bone metastases: a systematic review.Chow, E., Harris, K., Fan, G., et al.[2022]
Health Economic and Health Service Issues of Palliative Radiotherapy.Barton, M., Batumalai, V., Spencer, K.[2021]
Photon GRID Radiation Therapy: A Physics and Dosimetry White Paper from the Radiosurgery Society (RSS) GRID/LATTICE, Microbeam and FLASH Radiotherapy Working Group.Zhang, H., Wu, X., Zhang, X., et al.[2021]
Impact of dose size in single fraction spatially fractionated (grid) radiotherapy for melanoma.Zhang, H., Zhong, H., Barth, RF., et al.[2022]
Spatially Fractionated Radiotherapy (GRID) Prior to Standard Neoadjuvant Conventionally Fractionated Radiotherapy for Bulky, High-Risk Soft Tissue and Osteosarcomas: Feasibility, Safety, and Promising Pathologic Response Rates.Snider, JW., Molitoris, J., Shyu, S., et al.[2021]
Early clinical results of proton spatially fractionated GRID radiation therapy (SFGRT).Mohiuddin, M., Lynch, C., Gao, M., et al.[2022]
Dosimetric properties of megavoltage grid therapy.Reiff, JE., Huq, MS., Mohiuddin, M., et al.[2022]
Treatment Planning of Bulky Tumors Using Pencil Beam Scanning Proton GRID Therapy.Halthore, A., Fellows, Z., Tran, A., et al.[2023]
The dosimetric enhancement of GRID profiles using an external collimator in pencil beam scanning proton therapy.Smith, BR., Nelson, NP., Geoghegan, TJ., et al.[2023]
Dosimetric evaluation of new approaches in GRID therapy using nonconventional radiation sources.Martínez-Rovira, I., Fois, G., Prezado, Y.[2018]
Spatially fractionated (GRID) therapy for large and bulky tumors.Peñagarícano, JA., Griffin, R., Corry, P., et al.[2018]

References

Advancing the Role of Proton Therapy for Spine Metastases Through Diagnostic Scan-Based Planning. [2023]
Single dose radiotherapy in soft tissue tumoral masses: just enough palliation. [2022]
Palliative radiotherapy: current status and future directions. [2022]
Palliative radiotherapy trials for bone metastases: a systematic review. [2022]
Health Economic and Health Service Issues of Palliative Radiotherapy. [2021]
Photon GRID Radiation Therapy: A Physics and Dosimetry White Paper from the Radiosurgery Society (RSS) GRID/LATTICE, Microbeam and FLASH Radiotherapy Working Group. [2021]
Impact of dose size in single fraction spatially fractionated (grid) radiotherapy for melanoma. [2022]
Spatially Fractionated Radiotherapy (GRID) Prior to Standard Neoadjuvant Conventionally Fractionated Radiotherapy for Bulky, High-Risk Soft Tissue and Osteosarcomas: Feasibility, Safety, and Promising Pathologic Response Rates. [2021]
Early clinical results of proton spatially fractionated GRID radiation therapy (SFGRT). [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Dosimetric properties of megavoltage grid therapy. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Treatment Planning of Bulky Tumors Using Pencil Beam Scanning Proton GRID Therapy. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
The dosimetric enhancement of GRID profiles using an external collimator in pencil beam scanning proton therapy. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Dosimetric evaluation of new approaches in GRID therapy using nonconventional radiation sources. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Spatially fractionated (GRID) therapy for large and bulky tumors. [2018]