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NCT04106362

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma

Terminated Phase 2 Last updated 1 June 2023
What this trial tests

Phase 2 trial testing Cetuximab in Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 in 1 participant. Terminated before completion.

Timeline
14 January 2020
Primary endpoint
23 May 2023
23 May 2023

Quick facts

Lead sponsorJonsson Comprehensive Cancer Center
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment1
Start date14 January 2020
Primary completion23 May 2023
Estimated completion23 May 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 or Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well radiation therapy and cisplatin with or without cetuximab works in treating patients with human papillomavirus (HPV) positive, KRAS-variant stage III-IV oropharyngeal squamous cell carcinoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy, cisplatin, and cetuximab may work better in treating patients with HPV positive, KRAS-variant oropharyngeal squamous cell carcinoma compared to radiation therapy and cisplatin alone.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Deintensification of treatment for human papillomavirus-related oropharyngeal cancer: Current state and future directions.
    Bigelow EO, Seiwert TY, Fakhry C. · · 2020 · cited 55× · PMID 32247987 · DOI 10.1016/j.oraloncology.2020.104652
  2. Therapeutic Advances and Challenges for the Management of HPV-Associated Oropharyngeal Cancer.
    Muniz IAF, Araujo M, Bouassaly J, Farshadi F, et al · · 2024 · cited 4× · PMID 38612819 · DOI 10.3390/ijms25074009
  3. Recent Treatment Patterns of Oropharyngeal Cancer in Korea Based on the Expert Questionnaire Survey of the Korean Society for Head and Neck Oncology (KSHNO).
    Choi KH, Song JH, Kim YS, Kim JH, et al · · 2021 · cited 2× · PMID 33540495 · DOI 10.4143/crt.2020.973

Verify or expand the search:

Other trials of Cetuximab

Trials testing the same drug.

Other recruiting trials for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Currently open trials in the same condition.

Other Jonsson Comprehensive Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04106362.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing