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Adaptive Radiotherapy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT03096808
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : September 11, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
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, 2019
Estimated Study Completion Date : March 15, 2019


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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03096808


Contacts
Contact: C. Jillian Tsai, MD 631-623-4268 tsaic@mskcc.org
Contact: Nancy Lee, MD 212-639-3341

Locations
United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: C. Jillian Tsai, MD    631-623-4268      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: C. Jillian Tsai, MD    631-623-4268      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: C. Jillian Tsai, MD, PhD    631-623-4268      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: C. Jillian Tsai, MD    631-623-4268      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: C. Jillian Tsai, MD    631-623-4268      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: C. Jillian Tsai, MD    631-623-4268      
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: C. Jillian Tsai, MD    631-623-4268      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: C. Jillian Tsai, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03096808     History of Changes
Other Study ID Numbers: 17-148
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
ART
intensity modulated radiation therapy
IMRT

Additional relevant MeSH terms:
Laryngeal Diseases
Head and Neck Neoplasms
Mouth Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms
Paranasal Sinus Neoplasms
Nasopharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Nose Neoplasms
Nose Diseases
Paranasal Sinus Diseases
Nasopharyngeal Diseases