- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03096808
Adaptive Radiotherapy for Head and Neck Cancer
October 22, 2021 updated by: Memorial Sloan Kettering Cancer Center
A Prospective Non-Inferiority Trial of the Use of Adaptive Radiotherapy for Head and Neck Cancer Undergoing Radiation Therapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack
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Harrison, New York, United States, 10604
- Memoral Sloan Kettering Westchester
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre, New York, United States, 11570
- Memorial Sloan Kettering Rockville Centre
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with locoregional recurrence-free interval
Time Frame: 2 years
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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.
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: C. Jillian Tsai, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2017
Primary Completion (Actual)
October 22, 2021
Study Completion (Actual)
October 22, 2021
Study Registration Dates
First Submitted
March 15, 2017
First Submitted That Met QC Criteria
March 24, 2017
First Posted (Actual)
March 30, 2017
Study Record Updates
Last Update Posted (Actual)
October 26, 2021
Last Update Submitted That Met QC Criteria
October 22, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Paranasal Sinus Diseases
- Nose Diseases
- Laryngeal Diseases
- Nose Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Neoplasms
- Mouth Neoplasms
- Oropharyngeal Neoplasms
- Laryngeal Neoplasms
- Paranasal Sinus Neoplasms
Other Study ID Numbers
- 17-148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
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Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
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Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
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Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
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IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
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University of California, San FranciscoCompleted
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Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
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Radboud University Medical CenterUnknown
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Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on Adaptive Radiotherapy
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The University of Hong Kong-Shenzhen HospitalUnknownCervical Cancer | Artificial Intelligence | Radiotherapy Side Effect | BiomarkerChina
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University Hospital, EssenRecruitingCervical Carcinoma | Radiation | Adaptive Radiotherapy | Image Guided Radiotherapy | Gynecological Tumor | Optimization | Curative Treatment | Adaptive Radiation TherapyGermany
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Royal Marsden NHS Foundation TrustRecruitingHead and Neck CancerUnited Kingdom
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Lawson Health Research InstituteLondon Regional Cancer Program, CanadaTerminatedNon Small Cell Lung CancerCanada
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Columbia UniversityVarian Medical SystemsRecruitingGlioblastoma | Astrocytoma | Anaplastic Astrocytoma | Anaplastic OligodendrogliomaUnited States
-
Istituto Clinico HumanitasRecruitingHead and Neck CancerItaly
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University Hospital, EssenRecruitingHead and Neck Cancer | Optimized Treatment | Radiation | Adaptive Radiotherapy | Protection of Organs at Risk | Dysphagia ReductionGermany
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West China HospitalNot yet recruitingHigh-grade GliomaChina
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IRCCS Sacro Cuore Don Calabria di NegrarRecruiting
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Peking Union Medical College HospitalActive, not recruitingUterine Cervical NeoplasmChina