Adaptive Radiotherapy for Head and Neck Cancer

NCT03096808 | Completed Phase 2

• 1 other identifier: 17-148
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 8

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (1)

Adaptive Radiotherapy

EXPERIMENTAL

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

Interventions

Adaptive Radiotherapy 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.

Also known as: ART

Adaptive Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (8)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memoral Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms; Paranasal Sinus Neoplasms; Oropharyngeal Neoplasms; Mouth Neoplasms; Nasopharyngeal Neoplasms; Laryngeal Neoplasms; Hypopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Nose Neoplasms; Otorhinolaryngologic Neoplasms; Nose Diseases; Respiratory Tract Diseases; Paranasal Sinus Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Mouth Diseases; Nasopharyngeal Diseases; Laryngeal Diseases

Study Officials

• C. Jillian Tsai, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 30, 2017
• Study Start: March 15, 2017
• Primary Completion: October 22, 2021
• Study Completion: October 22, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

US (8)