Proton Re-Irradiation for Recurrent Head and Neck Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: conventionally fractionated full dose re-irradiation
* Radiation: hypofractionated palliative re-irradiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a phase II study evaluating proton reirradiation for patients who have a recurrent or a second primary head and neck cancer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fractionated full dose re-irradiation<br> | Radiation: conventionally fractionated full dose re-irradiation<br>* re-irradiation [60-70 Gy (RBE) in 2 Gy (RBE) fractions<br>|
| Experimental: hypofractionated palliative re-irradiation<br> | Radiation: hypofractionated palliative re-irradiation<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| locoregional recurrence-free | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proton Re-Irradiation, 17-300