Evaluation of Polyflex Stenting in Esophageal Cancer Patients
Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy
1 other identifier
observational
26
1 country
1
Brief Summary
To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2008
Typical duration 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
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 30, 2008
CompletedFirst Posted
Study publicly available on registry
August 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedAugust 3, 2020
March 1, 2018
2.9 years
July 30, 2008
July 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation
8 - 10 weeks
Study Arms (1)
Observation
Esophageal cancer patients
Eligibility Criteria
Esophageal cancer patients who have elected to have a stent placed.
You may qualify if:
- years of age and older
- Willing and able to provide informed consent
- Willing to comply with follow-up requirements
- Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less)
- Indicated for chemotherapy and/or radiation therapy
- Ability to dilate stricture to 15mm diameter at extent of disease evaluation
- Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent
You may not qualify if:
- Patients contraindicated for endoscopy
- Patients with prior esophageal stent placements
- Advance stage of disease, greater than T3 tumor or M1 disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Louisville
Louisville, Kentucky, 40202, United States
Related Publications (2)
Martin RC 2nd, Cannon RM, Brown RE, Ellis SF, Williams S, Scoggins CR, Abbas AE. Evaluation of quality of life following placement of self-expanding plastic stents as a bridge to surgery in patients receiving neoadjuvant therapy for esophageal cancer. Oncologist. 2014 Mar;19(3):259-65. doi: 10.1634/theoncologist.2013-0344. Epub 2014 Feb 24.
PMID: 24567281DERIVEDBrown RE, Abbas AE, Ellis S, Williams S, Scoggins CR, McMasters KM, Martin RC 2nd. A prospective phase II evaluation of esophageal stenting for neoadjuvant therapy for esophageal cancer: optimal performance and surgical safety. J Am Coll Surg. 2011 Apr;212(4):582-8; discussion 588-9. doi: 10.1016/j.jamcollsurg.2010.12.026.
PMID: 21463793DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Martin, MD
University of Louisville
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 30, 2008
First Posted
August 4, 2008
Study Start
March 1, 2008
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
August 3, 2020
Record last verified: 2018-03