NCT04444869

Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer

Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx "ENID"

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.

Detailed description

This is a trial of definitive chemotherapy and radiation therapy in human papilloma virus positive oropharyngeal cancers, in a population whose cancer is thought to be highly radio-sensitive. This is a population whose outcomes are already known to be very good with high rates of local and distant control of the disease. With the long term disease control and survival of patients with this disease, long term treatment toxicity and resulting reduction in quality of life poses new problems. This has lead to several studies to examine the role of radiation dose de-escalation through various strategies in attempt to reduce long term toxicity from treatment and yet achieve equivalent long term disease control. This trial specifically hypothesizes that a lower dose of radiation therapy to the clinically and radiographically uninvolved lymph nodes will no detrimental effect on loco-regional control or overall survival and will improve the long-term side effect profile, particularly with regards to xerostomia and dysphagia. The goal of this study is therefore to determine whether a lower dose to the clinically and radiographically uninvolved lymph nodes can be done safely and with better long-term toxicity profile and better overall quality of life without compromising the expected outcomes of progression free survival.

Conditions

• Cancer of the Head and Neck
• Oropharynx Cancer
• HPV Positive Oropharyngeal Squamous Cell Carcinoma
• Throat Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin injection	Standard dose cisplatin given concurrently with radiation therapy

Timeline

• Start date: 2020-09-28
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2020-06-24
• Last updated: 2024-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study