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Spots Global Cancer Trial Database for Shortened Course Adjuvant Radiotherapy Following TORS

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Trial Identification

Brief Title: Shortened Course Adjuvant Radiotherapy Following TORS

Official Title: A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma

Study ID: NCT05714657

Study Description

Brief Summary: This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected p16+ OPSCC patients receiving adjuvant radiation after TORS and neck dissection. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group and found to be safe and effective.

Detailed Description: This is a single-arm, phase II study of dose-reduced, adjuvant radiotherapy (10 treatments over 2 weeks) for patients with p16+ oropharyngeal squamous cell carcinoma after completion of transoral robotic resection (TORS) and selective neck dissection (SND). Selected patients will be required to have measurable preoperative circulating tumor human papillomavirus DNA (ctHPVDNA) and undetectable postoperative (pre-radiotherapy) ctHPVDNA. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group (AVOID trial, Swisher-McClure et al. 2020) and found to be safe and effective.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Pennsylvania Hospital, Philadelphia, Pennsylvania, United States

Contact Details

Name: Alexander Lin, MD

Affiliation: Abramson Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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