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

Breast Cancer Clinical Trial

— ReRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313191
• Other study ID #: NYPC ERC# 2019-002
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: January 2027

Study information

• Verified date: October 2023
• Source: The New York Proton Center
• Contact: Ryan Holder, BS
• Phone: 646-968-9055
• Email: research[@]nyproton.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Central Nervous System Neoplasms
• CNS Cancer
• GI Cancer
• Gynecologic Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Prostate Cancer
• Thoracic Cancer

Intervention

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

Locations

Country	Name	City	State
United States	The New York Proton Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
The New York Proton Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 years
Secondary	To determine the 1 year freedom from local failure.		1 year
Secondary	To determine the 1 year freedom from progression free survival.		1 year
Secondary	To determine the 1 year freedom from overall survival.		1 year
Secondary	To determine the acute cumulative rate of CTCAE v5.0 Grade =3 treatment related adverse events at 90 days of reirradiation completion.		90 days
Secondary	To determine the late cumulative rate of CTCAE v5.0 Grade =3 treatment related adverse events at 2 years of reirradiation completion.		2 years
Secondary	To characterize patient reported outcomes within 1 year of reirradiation using the MDASI BT forms for intracranial tumors.		1 years
Secondary	To characterize patient reported outcomes within 1 year of reirradiation using the CTB COMP forms for intracranial tumors.		1 years
Secondary	To characterize patient reported outcomes within 1 year of reirradiation using the MDASI SP form for spinal tumors.		1 year