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Adaptive Radiotherapy for Head and Neck Cancer

NCT ID: NCT03096808

Last Updated: 2021-10-26

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2021-10-22

Brief Summary

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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

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Conditions

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Head and Neck Cancer Paranasal Sinus Cancer Oropharynx Cancer Oral Cavity Cancer Nasopharynx Cancer Larynx Cancer Hypopharynx Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Adaptive Radiotherapy

Intervention Type RADIATION

ART involved modification of the radiation treatment plan during treatment course to account for temporal variations in anatomy due to changes in tumor volume and/or patients' weight loss.

Interventions

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Adaptive Radiotherapy

ART involved modification of the radiation treatment plan during treatment course to account for temporal variations in anatomy due to changes in tumor volume and/or patients' weight loss.

Intervention Type RADIATION

Other Intervention Names

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ART

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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C. Jillian Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Site Status

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status

Memoral Sloan Kettering Westchester

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, United States

Site Status

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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17-148

Identifier Type: -

Identifier Source: org_study_id