Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell
Observational Parallel Cohort Study of Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell Carcinoma
1 other identifier
observational
44
1 country
1
Brief Summary
The goal of this laboratory research study is to learn about symptoms and activity levels of patients with OPSCC that receive IMPT or TORS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 19, 2016
CompletedFirst Posted
Study publicly available on registry
January 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMay 23, 2019
May 1, 2019
4.9 years
January 19, 2016
May 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Objective Functional Outcome After Treatment with Either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) in Participants with Low-Risk Oropharynx Squamous Cell Carcinoma (OPSCC)
Functional outcome measured by using longitudinal digital wristband activity monitoring of study participants.
6 months
Objective Functional Outcome After Treatment with Either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) in Participants with Low-Risk Oropharynx Squamous Cell Carcinoma (OPSCC)
Functional outcome measured by using patient-reported outcome (PRO) measures from the M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDADI-HN).
6 Months
Study Arms (2)
Intensity-Modulated Proton Therapy or( IMPT) Group
Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months. Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months. Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.
TransOral Robotic Surgery (TORS) Group
Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months. Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months. Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.
Interventions
Intensity-Modulated Proton Therapy or( IMPT) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months. TransOral Robotic Surgery (TORS) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months.
Intensity-Modulated Proton Therapy or( IMPT) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months. TransOral Robotic Surgery (TORS) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months.
Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.
Eligibility Criteria
Participants having treatment with either proton therapy (called Intensity-Modulated Proton Therapy or IMPT) or robotic surgery (called TransOral Robotic Surgery or TORS) at MD Anderson Cancer Center in Houston, Texas.
You may qualify if:
- Age ≥ 18 years
- Histologically documented or suspected, previously untreated OPSCC (Clinical Stage I-Va; Tx,0-2, N0-2b) eligible for standard of care single-modality treatment with either IMPT or TORS. Patients with suspected OPSCC must have a diagnosis confirmed prior to treatment per the current clinical standard of care
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil Gross, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2016
First Posted
January 26, 2016
Study Start
January 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
May 23, 2019
Record last verified: 2019-05