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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA111603 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Mucosal Resection | Other | Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated. |
|
| Photodynamic Therapy | Other | Patients will have endoscopic mucosal resection with photodynamic therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Mucosal Resection | Procedure | Endoscopic mucosal resection at time of endoscopy if indicated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 12 months post therapy |
| Change in Quality of Life | Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36 | end of study |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth K. Wang, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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.
Patients were recruited from December 1, 2005 thru April 26, 2011 at Mayo Clinic in Rochester, Minnesota.
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| ID | Title | Description |
|---|---|---|
| FG000 | Endoscopic Mucosal Resection | Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated. |
| FG001 | Photodynamic Therapy | Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endoscopic Mucosl Resection | patients will undergo endoscopic mucosal resection at time of endoscopy if indicated |
| BG001 | Photodynamic Therapy | patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Number | paricipants | 12 months post therapy |
|
6 years, 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endoscopic Mucosl Resection | patients will undergo endoscopic mucosal resection at time of endoscopy if indicated |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal failure - Sepsis | Renal and urinary disorders | Non-systematic Assessment | unrelated to study participation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Gastrointestinal disorders | Non-systematic Assessment | known/anticipated risk - post endoscopic mucosal resection - treated endoscopically or observation only |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Wang MD | Mayo Clinic | 507-255-7495 | wang.kenneth@mayo.edu |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| D010778 | Photochemotherapy |
| D017323 | Dihematoporphyrin Ether |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Photodynamic Therapy | Procedure | Porfimer sodium 2mg/kg |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
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| Primary | 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. | 4 participants in the PDT group completed at least 3 months of follow up but not 12 months | Posted | Number | participants | 12 months post therapy |
|
|
|
|
| Primary | Change in Quality of Life | Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36 | 25 patients did not return completed SF36 at 12 month of follow up their results were not used in final analysis. | Posted | Number | participants | end of study |
|
|
|
|
| 1 |
| 36 |
| 3 |
| 36 |
| EG001 | Photodynamic Therapy | patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy. | 4 | 37 | 21 | 37 |
|
| Respitory Failure / Sepsis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | unrelated to study participation |
|
| heart attack resulting in death | Cardiac disorders | Non-systematic Assessment | not related to study participation |
|
|
| Dehydration | General disorders | Non-systematic Assessment | required hospitalization with IV fluids both incidents were unrelated to study participation |
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| Photosensitivity | Skin and subcutaneous tissue disorders | Non-systematic Assessment | known and anticipated risk of Photodynamic therapy (Photofrin) |
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| Atrial fibrilation | Cardiac disorders | Non-systematic Assessment | not related to study participation |
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| Pain | Gastrointestinal disorders | Non-systematic Assessment | Participant had pain last longer than is anticipated after photodynamic therapy, treated with medication |
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| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment | known and anticipated event post photodynamic therapy |
|
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| D004066 |
| Digestive System Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
| D017324 | Hematoporphyrin Derivative |
| D006415 | Hematoporphyrins |
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| no change or worsening of dysplasia post therapy |
|