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NCT Number: NCT05313191

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

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.

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Key information

Conditions

CNS Cancer Breast Cancer Breast Diseases Breast Neoplasms Central Nervous System Neoplasms Digestive System Diseases Digestive System Neoplasms GI Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gynecologic Cancer Head and Neck Cancer Head and Neck Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The New York Proton Center

New York, 10035, United States

Location status: Recruiting

Location contact

Isabelle Choi, MD

CONTACT

[email protected]

646-968-9060

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pencil Beam Scanning Proton Therapy

Radiation

Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies

Primary outcomes

  1. To determine the cumulative rate of CTCAE v5.0 Grade ≥3 acute and late treatment related adverse events within 1 year of definitive reirradiation completion using proton therapy for recurrent or second primary tumor.

    Time frame: 5 years

Secondary outcomes

  1. To determine the 1 year freedom from local failure.

    Time frame: 1 year

  2. To determine the 1 year freedom from progression free survival.

    Time frame: 1 year

  3. To determine the 1 year freedom from overall survival.

    Time frame: 1 year

  4. To determine the acute cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 90 days of reirradiation completion.

    Time frame: 90 days

  5. To determine the late cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 2 years of reirradiation completion.

    Time frame: 2 years

  6. To characterize patient reported outcomes within 1 year of reirradiation using the MDASI BT forms for intracranial tumors.

    Time frame: 1 years

  7. To characterize patient reported outcomes within 1 year of reirradiation using the CTB COMP forms for intracranial tumors.

    Time frame: 1 years

  8. To characterize patient reported outcomes within 1 year of reirradiation using the MDASI SP form for spinal tumors.

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan Holder, BS

CONTACT

[email protected]

646-968-9055 ext. 387

Sponsors and collaborators

Lead sponsor

The New York Proton Center

Other

Registry information

Acronym: ReRT

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 6, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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