Endoscopic Therapy of Early Cancer in Barretts Esophagus
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Endoscopic Mucosal Resection Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated. |
Procedure: Endoscopic Mucosal Resection
Endoscopic mucosal resection at time of endoscopy if indicated.
|
Other: Photodynamic Therapy Patients will have endoscopic mucosal resection with photodynamic therapy. |
Procedure: Endoscopic Mucosal Resection
Endoscopic mucosal resection at time of endoscopy if indicated.
Procedure: Photodynamic Therapy
Porfimer sodium 2mg/kg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Level of Dysplasia on Histology at 12 Months [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. [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 [end of study]
Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
-
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.
Exclusion criteria:
-
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Kenneth K. Wang, M.D., Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1399-05
- R01CA111603
Study Results
Participant Flow
Recruitment Details | Patients were recruited from December 1, 2005 thru April 26, 2011 at Mayo Clinic in Rochester, Minnesota. |
---|---|
Pre-assignment Detail | We intended to recruit 100 patients with early cancer and were able to recruit a total of 124 patients in this single center randomized trial. A total of 73 patients could actually be randomized due to inability to completely remove the cancer, finding evidence of high risk of metastasis, or refusing randomization to photodynamic therapy. |
Arm/Group Title | Endoscopic Mucosal Resection | Photodynamic Therapy |
---|---|---|
Arm/Group Description | Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated. | Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy. |
Period Title: Overall Study | ||
STARTED | 36 | 37 |
COMPLETED | 25 | 17 |
NOT COMPLETED | 11 | 20 |
Baseline Characteristics
Arm/Group Title | Endoscopic Mucosl Resection | Photodynamic Therapy | Total |
---|---|---|---|
Arm/Group Description | patients will undergo endoscopic mucosal resection at time of endoscopy if indicated | patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy. | Total of all reporting groups |
Overall Participants | 36 | 37 | 73 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
13
36.1%
|
12
32.4%
|
25
34.2%
|
>=65 years |
23
63.9%
|
25
67.6%
|
48
65.8%
|
Sex: Female, Male (Count of Participants) | |||
Female |
3
8.3%
|
6
16.2%
|
9
12.3%
|
Male |
33
91.7%
|
31
83.8%
|
64
87.7%
|
Region of Enrollment (participants) [Number] | |||
United States |
36
100%
|
37
100%
|
73
100%
|
Outcome Measures
Title | Level of Dysplasia on Histology at 12 Months |
---|---|
Description | All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus |
Time Frame | 12 months post therapy |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Endoscopic Mucosal Resection | Photodynamic Therapy |
---|---|---|
Arm/Group Description | Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated. | Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy. |
Measure Participants | 25 | 13 |
Decreases in dysplasia from enrollment |
10
|
11
|
No improvement or worsened level of dysplasia |
15
|
2
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Endoscopic Mucosal Resection, Photodynamic Therapy |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0098 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Fluorescence In Situ Hybridization (FISH) Markers at 12 Months. |
---|---|
Description | 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. |
Time Frame | 12 months post therapy |
Outcome Measure Data
Analysis Population Description |
---|
4 participants in the PDT group completed at least 3 months of follow up but not 12 months |
Arm/Group Title | Endoscopic Mucosal Resection FISH Polysomy Negative | Endoscopic Mucosal Resection FISH Positive Positive | Photodynamic Therapy FISH POSITIVE | Photodynamic Therapy FISH NEGATIVE |
---|---|---|---|---|
Arm/Group Description | FISH cytology results prior to therapy were negative | FISH cytology results were positive prior to therapy | FISH cytology results were positive prior to therapy | FISH cytology results prior to therapy were negative |
Measure Participants | 11 | 13 | 8 | 5 |
Decrease level of dysplasia post therapy |
7
19.4%
|
8
21.6%
|
6
8.2%
|
5
NaN
|
no change or worsening of dysplasia post therapy |
4
11.1%
|
5
13.5%
|
2
2.7%
|
0
NaN
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Endoscopic Mucosal Resection, Photodynamic Therapy |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.34 |
Comments | ||
Method | Chi-squared | |
Comments |
Title | Change in Quality of Life |
---|---|
Description | Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36 |
Time Frame | end of study |
Outcome Measure Data
Analysis Population Description |
---|
25 patients did not return completed SF36 at 12 month of follow up their results were not used in final analysis. |
Arm/Group Title | Endoscopic Mucosal Resection | Endoscopic Mucosal Resection and Photodynamic Therapy |
---|---|---|
Arm/Group Description | Patients will undergo EMR at time of endoscopy if indicated. | Patients will have EMR (if indicated at time of endoscopy) followed by photodynamic therapy |
Measure Participants | 10 | 6 |
qaulity of life remained the same of improved |
9
25%
|
6
16.2%
|
decrease in qualify of life |
1
2.8%
|
0
0%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Endoscopic Mucosal Resection, Photodynamic Therapy |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.2 |
Comments | ||
Method | Chi-squared | |
Comments | the only participant who reported a decrease quality of life related that to a recent surgery not their esophagus. |
Adverse Events
Time Frame | 6 years, 2 months | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Endoscopic Mucosl Resection | Photodynamic Therapy | ||
Arm/Group Description | patients will undergo endoscopic mucosal resection at time of endoscopy if indicated | patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy. | ||
All Cause Mortality |
||||
Endoscopic Mucosl Resection | Photodynamic Therapy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Endoscopic Mucosl Resection | Photodynamic Therapy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/36 (2.8%) | 4/37 (10.8%) | ||
Cardiac disorders | ||||
heart attack resulting in death | 1/36 (2.8%) | 1 | 2/37 (5.4%) | 2 |
Renal and urinary disorders | ||||
Renal failure - Sepsis | 0/36 (0%) | 0 | 1/37 (2.7%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||
Respitory Failure / Sepsis | 0/36 (0%) | 0 | 1/37 (2.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
Endoscopic Mucosl Resection | Photodynamic Therapy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/36 (8.3%) | 21/37 (56.8%) | ||
Cardiac disorders | ||||
Atrial fibrilation | 1/36 (2.8%) | 1 | 0/37 (0%) | 0 |
Gastrointestinal disorders | ||||
Bleeding | 1/36 (2.8%) | 1 | 1/37 (2.7%) | 1 |
Pain | 0/0 (NaN) | 0 | 1/37 (2.7%) | 1 |
Dysphagia | 0/36 (0%) | 0 | 6/37 (16.2%) | 6 |
General disorders | ||||
Dehydration | 1/36 (2.8%) | 1 | 1/37 (2.7%) | 1 |
Skin and subcutaneous tissue disorders | ||||
Photosensitivity | 0/36 (0%) | 0 | 12/37 (32.4%) | 12 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Kenneth Wang MD |
---|---|
Organization | Mayo Clinic |
Phone | 507-255-7495 |
wang.kenneth@mayo.edu |
- 1399-05
- R01CA111603