Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer

Phase 2

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Radiation: Proton beam radiotherapy (PBRT); Radiation: Photon intensity modulated radiation therapy (IMRT)

• Registration Number: NCT02923570
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-03
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Age greater than or equal to 18.

• Histopathologically confirmed diagnosis of one the following cancer types:

  • Salivary gland cancer
  • Skin cancer
  • Melanoma

• HNSCC that require ipsilateral radiation

• Patients must be a candidate for ipsilateral radiation therapy.

• Karnofsky performance status ≥70.

• Negative pregnancy test for women of childbearing potential (<51 years of age) as per institutional policy.

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Exclusion Criteria

• Any prior head or neck irradiation.
• Physician recommendation of bilateral neck radiation.
• Non-resectable disease
• Physician recommendation of mucosal radiation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proton beam radiotherapy (PBRT)	Proton beam radiotherapy (PBRT)	PBRT to standard dose of 60-66Gy
Photon intensity modulated radiation therapy (IMRT)	Photon intensity modulated radiation therapy (IMRT)	IMRT to standard dose of 60-66Gy

Primary Outcome Measures

Name	Time	Method
number of patients with grade 2 or greater acute mucositis	1 year	via the CTCAE v4.0.

Trial Locations

Locations (9)

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

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

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

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

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

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

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

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

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