Proton Re-Irradiation for Recurrent Head and Neck Cancer

Phase 2

Active, not recruiting

• Conditions: Head and Neck Cancer
• Interventions: Radiation: hypofractionated palliative re-irradiation; Radiation: conventionally fractionated full dose re-irradiation

• Registration Number: NCT03217188
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-10
• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypofractionated palliative re-irradiation	hypofractionated palliative re-irradiation	-
fractionated full dose re-irradiation	conventionally fractionated full dose re-irradiation	-

Primary Outcome Measures

Name	Time	Method
locoregional recurrence-free	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.

Trial Locations

Locations (9)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Baptist Alliance MCI; 🇺🇸 Miami, Florida, United States

Memorial Sloan Kettering Rockville Centre; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States