Evaluating Proton Therapy for Tumors Previously Treated with Radiation
Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors
This study is testing a new type of radiation therapy called proton therapy to see if it can help people with tumors that have already been treated with radiation, while causing less harm to healthy tissues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The New York Proton Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05313191 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Pencil Beam Scanning Proton Therapy for patients with tumors that have previously been treated with radiation. The study aims to explore different doses and scheduling of proton therapy to effectively target recurrent or new tumors while minimizing damage to surrounding healthy tissues. By utilizing proton therapy, which delivers radiation more precisely than traditional photon therapy, the trial seeks to improve treatment outcomes for patients with various types of cancer, including CNS, head and neck, GI, gynecologic, and prostate cancers.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a documented history of cancer and are in good physical condition.
Not a fit: Patients with non-malignant systemic diseases or those with a history of certain low-risk cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with recurrent tumors while reducing the risk of long-term side effects.
How similar studies have performed: Other studies have shown promise in using proton therapy for cancer treatment, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years * Patient provides study specific informed consent prior to study entry. * Documented history and physical exam within 90 days prior to registration. * ECOG PS 0, 1, or 2 within 90 days prior to registration Exclusion Criteria: * Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up. * Prior invasive non study malignancy unless disease free for ≥ 3 years * Non melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible. * History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
Where this trial is running
New York, New York
- The New York Proton Center — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Ryan Holder, BS
- Email: research@nyproton.com
- Phone: 646-968-9055
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.