Using proton therapy to treat large, inoperable tumors with GRID radiotherapy
A Phase I Trial of Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy
This study is testing a new way to use proton therapy combined with GRID radiotherapy to see if it can help people with large, inoperable tumors feel better and improve their treatment results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05831579 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of spatially fractionated radiotherapy (GRID) combined with intensity-modulated proton therapy for patients with unresectable solid tumors or metastatic cancer. The approach aims to create high-dose 'peaks' and low-dose 'valleys' within the tumor, potentially improving treatment efficacy while minimizing toxicity. Patients will receive three fractions of palliative radiotherapy, and the study will assess both the safety and effectiveness of this innovative treatment method. The hypothesis is that GRID therapy will yield better outcomes compared to traditional palliative radiotherapy.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed cancer and unresectable or metastatic tumors measuring at least 4.5 cm.
Not a fit: Patients with tumors that are resectable or those who have already received extensive radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide improved palliative care options for patients with large, inoperable tumors.
How similar studies have performed: While the GRID approach is innovative, similar spatially fractionated radiotherapy techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed cancer diagnosis. * Planning to undergo palliative radiotherapy to unresectable or metastatic target lesion ≥ 4.5 cm in any dimension as measured with radiographic imaging or with calipers by clinical exam. * Cohort A: 10 patients with lesions that have been previously irradiated. * Cohort B: 10 patients with lesions that have not been previously irradiated. * ECOG performance status ≤ 3 * At least 18 years of age. * Radiotherapy is known to be teratogenic. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after completion of the study * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: * Patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture and amenable to surgical intervention. * Patients with a superficial target lesion ≤ 1 cm deep to skin surface who initially had a superficial lesion irradiated, if the target lesion was in the area of the prior irradiation. * Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that will overlap with the proton GRID administration. * Cytotoxic chemotherapy and VEGF inhibitors prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist. This includes continuing a treatment plan which was initiated prior to the start of radiotherapy. A 2-week washout is recommended, but not required. * Pregnant. Women of childbearing potential must have a negative pregnancy test within 20 days of study entry. * Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Anthony Apicelli, M.D. — Washington University School of Medicine
- Study coordinator: Anthony Apicelli, M.D.
- Email: apicella@wustl.edu
- Phone: 314-362-8610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.