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

Memorial Sloan Kettering Cancer Center9 sites in 1 country87 target enrollmentJuly 10, 2017

ConditionsHead and Neck Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Head and Neck Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 87
Locations: 9
Primary Endpoint: locoregional recurrence-free
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 10, 2017

End Date

March 18, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.