Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Encinitas, California and other locations
Dates
study started
completion around
Principal Investigator
by Loren K. Mell

Description

Summary

This phase II/III trial compares whether cisplatin given weekly with radiation therapy is better tolerated than cisplatin given every three weeks with radiation therapy for the treatment of head and neck cancer that has spread to other places in the body (advanced). The second part of this study will also help to find out if the cisplatin given weekly approach will extend patients' life by at least the same amount of time as the cisplatin given every three weeks approach. Cisplatin is in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Radiation with low-dose cisplatin given weekly may be effective in shrinking or stabilizing head and neck cancer or preventing its recurrence.

Official Title

Randomized Phase II/III Trial of Radiation With Cisplatin at 100 mg/m2 Every Three Weeks Versus Radiation With Weekly Cisplatin at 40 mg/m2 for Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Details

Keywords

Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hypopharyngeal Squamous Cell Carcinoma, Advanced Laryngeal Squamous Cell Carcinoma, Advanced Oropharyngeal Squamous Cell Carcinoma, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Carcinoma, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms, Cisplatin, 1,2-diaminocyclohexaneplatinum II citrate, Computed Tomography, Magnetic Resonance Imaging, Positron Emission Tomography, Quality-of-Life Assessment, Radiation Therapy, radiation therapy, every 3 week cisplatin

Eligibility

Locations

  • UC San Diego Health System - Encinitas accepting new patients
    Encinitas California 92024 United States
  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UC San Diego Medical Center - Hillcrest accepting new patients
    San Diego California 92103 United States

Lead Scientist at UCSD

  • Loren K. Mell
    Professor, Radiation Medicine and Applied Science, Vc-health Sciences-schools. Authored (or co-authored) 210 research publications. Research interests: Personalized Medicine · Clinical Trials · Risk Modeling · Immune System · Imaging · Immunotherapy

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NRG Oncology
ID
NCT05050162
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 1714 study participants
Last Updated