Adaptive Radiotherapy for Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer; Paranasal Sinus Cancer; Nasopharynx Cancer; Hypopharynx Cancer; Oropharynx Cancer; Oral Cavity Cancer; Larynx Cancer
• Interventions: Radiation: Adaptive Radiotherapy

• Registration Number: NCT03096808
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to demonstrate that adaptive radiotherapy (ART) in head and neck cancer patients are comparable to historical controls in head and neck patients undergoing standard intensity-modulated radiation therapy (IMRT) without ART.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-30
• Status Verified: 2021-10
• Primary Completion: 2021-10-22
• Study Completion: 2021-10-22
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Participants with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy.
• Karnofsky performance status >= 70%
• Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
• Participants must have the ability to understand and the willingness to sign a written consent form

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Exclusion Criteria

• Female participants who are pregnant or breast feeding
• Participants who are not able to comply with study and/or follow up procedures
• Participants who have received induction chemotherapy before radiation treatment
• Participants who had prior head and neck radiation therapy
• Participants who are enrolled in a national/international cooperative group trials
• Patients with metastatic disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adaptive Radiotherapy	Adaptive Radiotherapy	Eligible patients will receive IMRT of 60-70Gy in 30-35 once-daily fractions with or without concurrent chemotherapy according to the current standard of care.

Primary Outcome Measures

Name	Time	Method
Number of patients with locoregional recurrence-free interval	2 years	This is assessed by imaging studies and/or physical exams at follow- up visits. This will include a diagnostic FDG PET/CT scan. CT and/or MRI of the primary site and neck will also be recommended. Patients will be classified as locoregional recurrence-free as long as there is no evidence of locoregional recurrence of disease by clinical evaluation, CT, MRI, and/or PET-CT according to the standard of care. For patients achieving complete response of disease, no further imaging study is necessary.

Trial Locations

Locations (8)

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

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

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

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

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

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