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Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02663583
First received: January 19, 2016
Last updated: July 21, 2016
Last verified: July 2016
  Purpose
The goal of this laboratory research study is to learn about symptoms and activity levels of patients with OPSCC that receive IMPT or TORS.

Condition Intervention
Cancer of the Mouth
Oropharynx Squamous Cell Carcinoma
Behavioral: Symptom Questionnaires
Behavioral: Dysphagia Inventory Questionnaire
Behavioral: Activity Bands

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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) [ Time Frame: 6 months ]
    Functional outcome measured by using longitudinal digital wristband activity monitoring of study participants.

  • 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) [ Time Frame: 6 Months ]
    Functional outcome measured by using patient-reported outcome (PRO) measures from the M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDADI-HN).


Estimated Enrollment: 44
Study Start Date: January 2016
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned 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.

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.

Behavioral: Symptom Questionnaires

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.

Other Name: Surveys
Behavioral: Dysphagia Inventory Questionnaire

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.

Other Name: Survey
Behavioral: Activity Bands
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.

Behavioral: Symptom Questionnaires

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.

Other Name: Surveys
Behavioral: Dysphagia Inventory Questionnaire

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.

Other Name: Survey
Behavioral: Activity Bands
Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Histologically documented, previously untreated OPSCC (Clinical Stage I-III; Tx,0-2, N0-1) eligible for standard of care single-modality treatment with either IMPT or TORS
  3. Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02663583

Contacts
Contact: Neil Gross, MD 713-792-6920

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: MD Anderson Health Information Specialist    877-632-6789      
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Neil Gross, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02663583     History of Changes
Other Study ID Numbers: PA15-0744 
Study First Received: January 19, 2016
Last Updated: July 21, 2016

Keywords provided by M.D. Anderson Cancer Center:
Oropharynx squamous cell carcinoma
Intensity-Modulated Proton Therapy
OPSCC
Actigraph accelerometer
MD Anderson Symptom Inventory - Head and Neck module
MDASI-HN
IMPT
TransOral Robotic Surgery
TORS
Surveys
Questionnaires

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on February 20, 2017