TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck
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|ClinicalTrials.gov Identifier: NCT03729518|
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Oropharyngeal Cancer Squamous Cell Carcinoma Human Papilloma Virus||Radiation: Radiation Therapy (IMRT or IMPT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Volume and Dose De-Intensification Following Transoral Robotic Surgery (TORS) and Neck Dissection for p16+ Oropharyngeal Squamous Cell Carcinoma|
|Actual Study Start Date :||October 11, 2018|
|Estimated Primary Completion Date :||October 11, 2022|
|Estimated Study Completion Date :||October 11, 2024|
Experimental: Arm 1
All patients will have the volume treated and radiation dose delivered to the regional lymphatics decreased according to the characteristics of the primary site and involved lymph nodes. The high risk neck will receive 50 Gy instead of 60 Gy, and the treated volume of the contralateral low risk neck will be reduced and receive only 45 Gy.
Radiation: Radiation Therapy (IMRT or IMPT)
- 2-year locoregional control [ Time Frame: 2 years ]Number of patients with 2-year locoregional control, defined as control at the primary site and in the neck, in patients undergoing de-intensified radiation to the primary site and regional lymphatics after Transoral Robotic Surgery (TORS) and neck dissection for p16+ oropharyngeal squamous cell carcinoma (OPSCC)
- Treatment-related toxicity [ Time Frame: 2 years ]Number of participants with treatment-related toxicity as gauged by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. the CTCAE v.5 utilizes a five point scale to report Adverse Events (AEs), defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure (cancer.gov)
- 2-year progression-free survival [ Time Frame: 3 years ]Number of participants with 2-year progression-free survival, defined as the length of time during and after treatment that a patient lives with the disease but it does not get worse (nih.gov)
- Differences in toxicity between Intensity-modulated radiation therapy (IMRT) and Intensity Modulated Proton Therapy (IMPT) [ Time Frame: 1 year ]Differences in toxicity outcomes in patients treated with IMRT versus proton therapy
- Number of participants with change in circulating human papillomavirus(HPV) DNA over the course of treatment [ Time Frame: 2 years ]Number of patients with a change in circulating HPV cells during the course of treatment, determined using a next generation sequencing (NGS) assay developed to detect HPV DNA in HPV+ oropharyngeal squamous cell carcinoma patients.
- Metastasis-free survival [ Time Frame: 3 years ]Number of participants with metastasis-free survival
- Patient reported quality of life outcomes [ Time Frame: 2.5 years ]Patient reported quality of life (QOL) outcomes using MD Anderson Symptom Inventory (MDASI) Head and Neck survey between patients treated with IMRT and IMPT. The MDASI-HN assesses the severity of symptoms in the last 24 hours using a 0-10 scale, with 0 being "not present" and 10 being "as bad as you can imagine". The interference of symptoms in the last 24 hours is assessed using a 0-10 scale, with 0 being "did not interfere" and 10 being "interfered completely". The mean of symptom severity and interference can be used to represent overall symptom distress and can be analyzed for changes over treatment and during follow-up.
- Overall survival [ Time Frame: 5 years ]Number of patients with overall survival, as defined by the length of time from the date of diagnosis or start of treatment for a disease that patients diagnosed with the disease are still alive (cancer.gov)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729518
|Contact: J. Nicholas Lukens, MD||855-216-0098||PennCancerTrials@emergingmed.com|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|