Early Stage Esophageal AdenocarcinomaPhase 2NCT00217087

Endoscopic Therapy of Early Cancer in Barretts Esophagus

A Phase 2 study testing Endoscopic Mucosal Resection and Photodynamic Therapy in people with Early Stage Esophageal Adenocarcinoma and Barrett Esophagus, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Early Stage Esophageal Adenocarcinoma, Barrett Esophagus
What is being tested?: Endoscopic Mucosal Resection and Photodynamic Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 1 siteUnited States
Study dates: Sep 2005to Jun 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Non-recurrent adenocarcinoma in Barrett's Esophagus confirmed by two experienced gastrointestinal pathologists
No evidence of submucosal invasion
No evidence of metastatic disease in either regional or distal lymph nodes, or other organs
Pre-entry CT scans of the upper abdomen and chest and Endoscopic Ultrasound (EUS) of the tumor and regional lymph nodes are required. Fusion PET scans are suggested for any indeterminate lesions
Zubrod Performance Status 0-1
Participants must be have oral intake of greater than 1700 calories a day

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Patient must not have had a second malignancy, other than curable non-melanoma skin cancer or cervical cancer in situ, unless disease free for greater than or equal to 3 years and deemed cured by their hematologist and/or oncologist
Staging procedures should be performed prior to study entry
All patients or legally authorized representative must sign a study-specific informed consent prior to randomization.

Who cannot join

Prior major esophageal surgery
Patients who are unable to tolerate endoscopic procedures
Due to the possible toxic effects of photodynamic therapy and endoscopic sedation to embryos, pregnant or lactating women or men unable or unwilling to practice contraception are excluded
Patients with an uncontrolled diabetes, heart disease, or hypertension
Patient and/or legally authorized representative who are unable to comprehend the study requirements or who are not likely to comply with the study parameters.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

This study is being done to see if treatment for esophageal cancer can be done using endoscopy for patients ineligible for surgical or radiological therapy. The standard method of treating this type of cancer is surgical removal of the esophagus. The study will determine if removing just the cancer with endoscopy is enough treatment or if the addition of another treatment called photodynamic therapy (treatment with a red light and a drug called sodium porfimer) is needed.

Read the detailed description

Participant visit requirements: Screening visit which will last 1 - 2 days, if assigned to photodynamic therapy, there will be a 3 day visit for treatment. Participants must return for a 1 day visit every three months for one year.

Conditions: Early Stage Esophageal Adenocarcinoma, Barrett Esophagus
Being tested: Endoscopic Mucosal Resection, Photodynamic Therapy
Medical subject headings: Barrett Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endoscopic Mucosal ResectionProcedure or surgery
Endoscopic mucosal resection at time of endoscopy if indicated.
Photodynamic TherapyProcedure or surgery
Also called Photofrin
Porfimer sodium 2mg/kg

Study groups in NCT00217087
Study group	Role	What they receive
Endoscopic Mucosal Resection	Other	Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated. Receives: Procedure: Endoscopic Mucosal Resection
Photodynamic Therapy	Other	Patients will have endoscopic mucosal resection with photodynamic therapy. Receives: Procedure: Endoscopic Mucosal Resection; Procedure: Photodynamic Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Level of Dysplasia on Histology at 12 Months
All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus
Measured: 12 months post therapy
Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.
Whether or not positive fish markers measured by polysomy were associated with outcomes.
Markers in this study include: 9q21 /017q (her2) / 8q24/ 20q / CEP17 / 17p. Polysomy and Trisomy were documented.
Measured: 12 months post therapy
Change in Quality of Life
Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36
Measured: end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Jun 2012

First posted22 Sep 2005 (estimated)
Study startSep 2005
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Early Stage Esophageal AdenocarcinomaStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00217087
Sponsor's protocol ID: 1399-05
Other IDs: R01CA111603
Status last verified: Nov 2015
First submitted: 20 Sep 2005
Last updated: 24 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Endoscopic Therapy of Early Cancer in Barretts Esophagus
ClinicalTrials.gov ID: NCT00217087
Acronym / sponsor ID: 1399-05
Conditions: Early Stage Esophageal Adenocarcinoma, Barrett Esophagus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Sep 2005
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 22 Sep 2005 (estimated)
Results: Posted 25 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Endoscopic Mucosal Resection	Other	Procedure: Endoscopic Mucosal ResectionPatients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
Photodynamic Therapy	Other	Procedure: Endoscopic Mucosal Resection, Procedure: Photodynamic TherapyPatients will have endoscopic mucosal resection with photodynamic therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Non-recurrent adenocarcinoma in Barrett's Esophagus confirmed by two experienced gastrointestinal pathologists
No evidence of submucosal invasion
No evidence of metastatic disease in either regional or distal lymph nodes, or other organs
Pre-entry CT scans of the upper abdomen and chest and Endoscopic Ultrasound (EUS) of the tumor and regional lymph nodes are required. Fusion PET scans are suggested for any indeterminate lesions
Zubrod Performance Status 0-1

Key exclusion criteria (5 listed)

Prior major esophageal surgery
Patients who are unable to tolerate endoscopic procedures
Due to the possible toxic effects of photodynamic therapy and endoscopic sedation to embryos, pregnant or lactating women or men unable or unwilling to practice contraception are excluded
Patients with an uncontrolled diabetes, heart disease, or hypertension
Patient and/or legally authorized representative who are unable to comprehend the study requirements or who are not likely to comply with the study parameters.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Endoscopic Mucosal ResectionEndoscopic mucosal resection at time of endoscopy if indicated.	Procedure or surgery	Endoscopic Mucosal Resection, Photodynamic Therapy
Photodynamic TherapyAlso: PhotofrinPorfimer sodium 2mg/kg	Procedure or surgery	Photodynamic Therapy

Primary outcome

Level of Dysplasia on Histology at 12 Months
Time frame: 12 months post therapy
All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus
Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.
Time frame: 12 months post therapy
Whether or not positive fish markers measured by polysomy were associated with outcomes. Markers in this study include: 9q21 /017q (her2) / 8q24/ 20q / CEP17 / 17p. Polysomy and Trisomy were documented.
Change in Quality of Life
Time frame: end of study
Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36

Results and safety

Results posted to the registry on 25 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Endoscopic Mucosal Resection	36	25
Photodynamic Therapy	37	17

Primary outcome: Level of Dysplasia on Histology at 12 Months

Time frame: 12 months post therapy. Number. Unit: paricipants

Measure	Endoscopic Mucosal Resection n = 25	Photodynamic Therapy n = 13
Decreases in dysplasia from enrollment	10	11
No improvement or worsened level of dysplasia	15	2

Endoscopic Mucosal Resection vs Photodynamic Therapy: p = 0.0098, Fisher Exact

Population analysed: 4 participants in the photodynamic therapy group completed at least 3 but less than 12 months follow up post therapy, so they were not included in this analysis.

Primary outcome: Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.

Time frame: 12 months post therapy. Number. Unit: participants

Measure	Endoscopic Mucosal Resection FISH Polysomy Negative n = 11	Endoscopic Mucosal Resection FISH Positive Positive n = 13	Photodynamic Therapy FISH POSITIVE n = 8	Photodynamic Therapy FISH NEGATIVE n = 5
Decrease level of dysplasia post therapy	7	8	6	5
no change or worsening of dysplasia post therapy	4	5	2	0

Endoscopic Mucosal Resection FISH Polysomy Negative vs Endoscopic Mucosal Resection FISH Positive Positive: p = 0.34, Chi-squared

Population analysed: 4 participants in the PDT group completed at least 3 months of follow up but not 12 months

Primary outcome: Change in Quality of Life

Time frame: end of study. Number. Unit: participants

Measure	Endoscopic Mucosal Resection n = 10	Endoscopic Mucosal Resection and Photodynamic Therapy n = 6
qaulity of life remained the same of improved	9	6
decrease in qualify of life	1	0

Endoscopic Mucosal Resection vs Endoscopic Mucosal Resection and Photodynamic Therapy: p = 0.2, Chi-squared

Population analysed: 25 patients did not return completed SF36 at 12 month of follow up their results were not used in final analysis.

Adverse events

Time frame: 6 years, 2 months. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Endoscopic Mucosl Resection	1 of 36 (2.8%)	3 of 36 (8.3%)	Not reported
Photodynamic Therapy	4 of 37 (10.8%)	21 of 37 (56.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
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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.

Kenneth K. Wang, M.D. principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 5 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 24 Dec 2015. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Level of Dysplasia on Histology at 12 Months (time frame: 12 months post therapy). The study lists 3 primary outcomes in all. 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 NCT00217087.

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 24 Dec 2015.