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Adaptive Radiotherapy for Head and Neck Cancer

Primary Purpose

Head and Neck Cancer, Paranasal Sinus Cancer, Oropharynx Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adaptive Radiotherapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring adaptive radiotherapy, ART, intensity modulated radiation therapy, IMRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Bergen
  • Memorial Sloan Kettering Commack
  • Memoral Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Rockville Centre
  • Memorial Sloan Kettering Nassau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adaptive Radiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patients with locoregional recurrence-free interval
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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2017
Last Updated
October 22, 2021
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03096808
Brief Title
Adaptive Radiotherapy for Head and Neck Cancer
Official Title
A Prospective Non-Inferiority Trial of the Use of Adaptive Radiotherapy for Head and Neck Cancer Undergoing Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
October 22, 2021 (Actual)
Study Completion Date
October 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Paranasal Sinus Cancer, Oropharynx Cancer, Oral Cavity Cancer, Nasopharynx Cancer, Larynx Cancer, Hypopharynx Cancer
Keywords
adaptive radiotherapy, ART, intensity modulated radiation therapy, IMRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adaptive Radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Adaptive Radiotherapy
Other Intervention Name(s)
ART
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with locoregional recurrence-free interval
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Jillian Tsai, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memoral Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville Centre
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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Adaptive Radiotherapy for Head and Neck Cancer

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