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Adaptive Radiotherapy for Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03096808
Recruitment Status : Active, not recruiting
First Posted : March 30, 2017
Last Update Posted : February 26, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Paranasal Sinus Cancer Oropharynx Cancer Oral Cavity Cancer Nasopharynx Cancer Larynx Cancer Hypopharynx Cancer Radiation: Adaptive Radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Non-Inferiority Trial of the Use of Adaptive Radiotherapy for Head and Neck Cancer Undergoing Radiation Therapy
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : March 15, 2021

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.
Radiation: 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.
Other Name: ART

Primary Outcome Measures :
  1. Number of patients with locoregional recurrence-free interval [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03096808

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United States, New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memoral Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, United States, 11570
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Principal Investigator: C. Jillian Tsai, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT03096808    
Other Study ID Numbers: 17-148
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
adaptive radiotherapy
intensity modulated radiation therapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mouth Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms
Paranasal Sinus Neoplasms
Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Nose Neoplasms
Nose Diseases
Paranasal Sinus Diseases
Nasopharyngeal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type