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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests different doses and schedules of proton therapy, a type of targeted radiation treatment. It is for people with tumors in an area already treated with radiation. Researchers want to learn whether proton therapy can treat these tumors better while limiting harm to nearby healthy tissue.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The listed age requirement is 18 years.
  • You must give informed consent, meaning you agree to join after learning about the study.
  • You must have a recorded health history and physical exam within 90 days before signing up.
  • Within 90 days before signing up, you must have an ECOG activity score of 0, 1, or 2. This means you can care for yourself and are up and about at least half of your waking hours.

Who can't join

  • You have a disease other than cancer that would keep you from getting study treatment or completing follow-up visits.
  • You had another invasive cancer, meaning cancer that grew into nearby tissue, unless you have been free of it for at least 3 years. Exceptions include non-melanoma skin cancer, low-risk prostate cancer, certain thyroid cancers, cancers that have not spread beyond where they started, and tumors not expected to shorten your life.
  • You have a history of an active connective tissue disease, such as lupus or scleroderma, which can affect skin, joints, or organs.
  • You have a history of dermatomyositis, a disease that causes muscle swelling and skin rash, or xeroderma pigmentosum, a disease that makes skin very sensitive to sunlight.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

NY