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

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT04444869
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin injection — DRUG
    Standard dose cisplatin given concurrently with radiation therapy

Study Details

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.

Key Dates

Start date
Sep 28, 2020
Status verified
May 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Open label single-arm study
    All patients will receive concurrent cisplatin and radiation therapy with radiation dose de-escalation to clinically and radiologically uninvolved lymph nodes.

Primary Outcome Measure

Rate of PEG tube placement [ Time Frame: During the procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MissouriColumbiaMissouri65203
Gregory Biedermann, MD
[email protected]
573-884-8264
Ken Baker, RN
[email protected]
(573) 884-6479

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By research site
University of Missouri· Columbia, MO

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