Proton Re-Irradiation for Recurrent Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2026-07-31

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.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a phase II study evaluating proton reirradiation for patients who have a recurrent or a second primary head and neck cancer.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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fractionated full dose re-irradiation

Group Type EXPERIMENTAL

conventionally fractionated full dose re-irradiation

Intervention Type RADIATION

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

hypofractionated palliative re-irradiation

Group Type EXPERIMENTAL

hypofractionated palliative re-irradiation

Intervention Type 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).

Interventions

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conventionally fractionated full dose re-irradiation

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

Intervention Type RADIATION

hypofractionated palliative re-irradiation

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).

Intervention Type RADIATION

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No