RECRUITING

Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. In some cases, the cancer either returns or a new tumor can present in a different part of the body. With the usual radiation treatment, the photon beams travel all the way through the body. As a result, healthy tissues in front of and behind the tumor are exposed to radiation. Physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. This dose is often not strong enough to destroy the cancerous tumor. Alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. Proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor. The reason we are conducting this research study is to look at whether Proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date.

Official Title

Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors

Quick Facts

Study Start:2022-01-24
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05313191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years
  2. * Patient provides study specific informed consent prior to study entry.
  3. * Documented history and physical exam within 90 days prior to registration.
  4. * ECOG PS 0, 1, or 2 within 90 days prior to registration
  1. * Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up.
  2. * Prior invasive non study malignancy unless disease free for ≥ 3 years
  3. * 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.
  4. * History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum

Contacts and Locations

Study Contact

Ryan Holder, BS
CONTACT
646-968-9055
research@nyproton.com

Study Locations (Sites)

The New York Proton Center
New York, New York, 10035
United States

Collaborators and Investigators

Sponsor: The New York Proton Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-24
Study Completion Date2027-01

Study Record Updates

Study Start Date2022-01-24
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Reirradiation
  • Cancer
  • Proton Therapy
  • Radiation Therapy

Additional Relevant MeSH Terms

  • CNS Cancer
  • Head and Neck Cancer
  • GI Cancer
  • Gynecologic Cancer
  • Prostate Cancer
  • Thoracic Cancer
  • Breast Cancer