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NCT05313191 | RECRUITING | CNS Cancer

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

The New York Proton Center

Brief Summary:

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.

Condition or disease

CNS Cancer

Head and Neck Cancer

Gi Cancer

Gynecologic Cancer

Prostate Cancer

Thoracic Cancer

Breast Cancer

Intervention/treatment

Pencil Beam Scanning Proton Therapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 1800 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors
Actual Study Start Date : 2022-01-24
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2027-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors

Location Details

NCT05313191

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

The New York Proton Center

New York, New York, United States, 10035