Proton Re-Irradiation for Recurrent Head and Neck Cancer

  • STATUS
    Recruiting
  • End date
    Jul 2, 2023
  • participants needed
    88
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 2 July 2022
metastasis
primary tumor
recurrent head and neck carcinoma

Summary

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.

Details
Condition Head and Neck Cancer
Treatment conventionally fractionated full dose re-irradiation, hypofractionated palliative re-irradiation
Clinical Study IdentifierNCT03217188
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on2 July 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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