Adaptive Radiotherapy for Head and Neck Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Oropharynx Cancer; Hypopharynx Cancer; Nasopharynx Cancer; Oral Cavity Cancer; Paranasal Sinus Cancer; Larynx Cancer; Head and Neck Cancer

Treatments: Radiation: Adaptive Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03096808

17-148

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Adaptive Radiotherapy

Experimental group

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.

Treatment:

Radiation: Adaptive Radiotherapy