OPSCC N0 Nodal Control With Reduced IMRT

NCT01891695 | Terminated Results DMC

• 1 other identifier: 16766
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• N0 Nodal Control Rate

  Effectiveness of 39.6 Gy (Gray) radiation on tumor control in the clinically uninvolved (N0) cervical lymphatics of patients with p16+ oropharyngeal squamous cell carcinoma (OPSCCA)

  Up to 3 years post treatment

Secondary Outcomes (3)

• Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck

  Up to 3 years post treatment

• Progression Free Survival Following 39.6 Gy Radiation to the Clinically Uninvolved Neck

  Up to 3 years post treatment

• Dose Volume Histograms (DVH)

  Up to 3 years post treatment

Study Arms (1)

Reduced Intensity Radiation

EXPERIMENTAL

39.6 Gy radiation to clinically uninvolved cervical lymphatics

Radiation: 39.6 Gy radiation

Interventions

39.6 Gy radiation RADIATION

Reduced Intensity Radiation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul W. Read, MD: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paul Read, MD
• Organization: University of Virginia

pwr3u@hscmail.mcc.virginia.edu

434-924-5191

Study Officials

• Paul W Read, MD, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: July 3, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 12, 2022
• Results First Posted: October 12, 2022

Record last verified: 2022-09

Locations

US (1)