Proton Re-Irradiation for Recurrent Head and Neck Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
Inactive
ClinicalTrials ID:NCT03217188
This study assesses tumor control and side effects of proton therapy in patients with recurrent or new primary head and neck cancer. Eligible participants are adults with prior radiation history and unresectable tumors. Interventions include full dose re-irradiation (60-70 Gy) or palliative "Quad Shot" therapy, based on life expectancy and health status.
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Program Overview
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.
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
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