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Completed

NCT Number: NCT03217188

Proton Re-Irradiation for Recurrent Head and Neck Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baptist Alliance MCI, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

conventionally fractionated full dose re-irradiation

Radiation

re-irradiation [60-70 Gy (RBE) in 2 Gy (RBE) fractions

hypofractionated palliative re-irradiation

Radiation

course or a hypofractionated palliative re-irradiation "Quad Shot" course (3.7 Gy (RBE) twice daily x 2 days, followed by a 4 week break [+/- 2 weeks], repeated up to 4 cycles).

Primary outcomes

  1. locoregional recurrence-free

    Time frame: 12 months

    Locoregional recurrence includes events of local and/or regional recurrence, or death due to any cause. Patients who are lost to follow-up without any event may be removed from the protocol at the discretion of the principal investigator.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Phase II Study of Proton Re-Irradiation for Recurrent Head and Neck Cancer

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2017
Registry last updated
Mar 23, 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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