OPSCC N0 Nodal Control With Reduced IMRT

NCT ID: NCT01891695

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-12-31

Brief Summary

The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering.

The purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.

Detailed Description

A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx.

Conditions

Oropharyngeal Squamous Cell Carcinoma (OPSCCA); HPV (Human Papillomavirus)-Associated

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reduced Intensity Radiation

39.6 Gy radiation to clinically uninvolved cervical lymphatics

Group Type: EXPERIMENTAL

39.6 Gy radiation

Intervention Type: RADIATION

Interventions

39.6 Gy radiation

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• patient must be clinically referred for radiation for stage I-IVb OPSCCA
• tumor must be HPV-associated p16+
• patient must be able to lie flat and tolerate immobilization systems

Exclusion Criteria

• patients may not be receiving any investigational agents
• prior radiation to head and neck
• any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years
• any major medical, psychiatric, or neurologic illness
• pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paul W. Read, MD

OTHER

Sponsor Role: lead

Responsible Party

Paul W. Read, MD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paul W Read, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Health System

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

16766

Identifier Type: -

Identifier Source: org_study_id