Proton Re-Irradiation for Recurrent Head and Neck Cancer

Completed · Phase 2

Conditions studied: Head and Neck Cancer

In brief

The purpose of this study is to evaluate the tumor control and the side effects of using proton therapy for head and neck cancer that has come back.

Key facts

Study ID

NCT03217188

Run by

Memorial Sloan Kettering Cancer Center

People needed

87

Starts

2017-07-10

Expected to finish

2026-03-18

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient willing and able to provide written informed consent
• Age ≥18 years at the time of consent
• Pathologically confirmed diagnosis of a recurrent or a new primary head and neck cancer
• A history of prior radiation to the head and neck (>/= 40 Gy, in 2 Gy/fraction equivalent)
• The recurrent or the second primary tumor is unresectable, the patient elects against surgical resection; patients who underwent surgery who has indications for postoperative radiation therapy is also eligible
• Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment Note: Patient with <6 months of life expectancy will be treated with palliative QUAD shot radiotherapy and those with > 6 months of life expectancy will be treated with conventionally fractionated full dose re-irradiation approach. Additional other factors determining which patients will be treated with Quad Shot therapy rather than full dose are if the patients have poor performance status, bulky or diffuse disease, significant medical co-morbidities, and significant metastatic disease burden.

You may not qualify if…

• Women who are pregnant or lactating
• Inability to comply with study and/or follow-up procedures
• <6 months between completion of prior RT and initiation of reirradiation using proton therapy

Where it is running

• Baptist Alliance MCI — Miami, Florida, United States
• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Rockville Centre — Rockville Centre, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.