Esophageal CancerNCT00727376
Evaluation of Polyflex Stenting in Esophageal Cancer Patients
An observational study of Esophageal Cancer, run by University of Louisville at 1 site in United States.
Trial summary
To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Esophageal cancer patients who have elected to have a stent placed.
Who may be able to join
- 18 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
Who cannot join
- Patients contraindicated for endoscopy
- Patients with prior esophageal stent placements
- Advance stage of disease, greater than T3 tumor or M1 disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy
To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.
- Conditions
- Esophageal Cancer
- Keywords
- esophageal, stenting
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Esophageal cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation
Measured: 8 - 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert C. Martin, University of Louisville
- Investigators
- Robert Martin, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727376
- Sponsor's protocol ID
- 08-0132
- Status last verified
- Mar 2018
- First submitted
- 30 Jul 2008
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24567281Brown 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.
PubMed 21463793
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy
- ClinicalTrials.gov ID
- NCT00727376
- Acronym / sponsor ID
- 08-0132
- Conditions
- Esophageal Cancer
- Keywords
- esophageal, stenting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 4 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Esophageal cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Esophageal cancer patients who have elected to have a stent placed.
Key inclusion criteria (7 listed)
- 18 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
Key exclusion criteria (3 listed)
- Patients contraindicated for endoscopy
- Patients with prior esophageal stent placements
- Advance stage of disease, greater than T3 tumor or M1 disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation
Time frame: 8 - 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Derived from this study: PubMed 24567281Martin 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.
- Derived from this study: PubMed 21463793Brown 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Martin, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation (time frame: 8 - 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00727376, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.