Trial Outcomes & Findings for Endoscopic Therapy of Early Cancer in Barretts Esophagus (NCT NCT00217087)

NCT ID: NCT00217087

Last Updated: 2015-12-24

Results Overview

All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 73 participants
• Primary outcome timeframe: 12 months post therapy
• Results posted on: 2015-12-24

Participant Flow

Patients were recruited from December 1, 2005 thru April 26, 2011 at Mayo Clinic in Rochester, Minnesota.

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.

Participant milestones

Measure	Endoscopic Mucosal Resection Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.	Photodynamic Therapy Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
Overall Study STARTED	36	37
Overall Study COMPLETED	25	17
Overall Study NOT COMPLETED	11	20

Reasons for withdrawal

Measure	Endoscopic Mucosal Resection Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.	Photodynamic Therapy Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
Overall Study decided to have esophagectomy	1	2
Overall Study completed less than 12 months return	10	18

Baseline Characteristics

Endoscopic Therapy of Early Cancer in Barretts Esophagus

Baseline characteristics by cohort

Measure	Endoscopic Mucosl Resection n=36 Participants patients will undergo endoscopic mucosal resection at time of endoscopy if indicated	Photodynamic Therapy n=37 Participants patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=93 Participants	12 Participants n=4 Participants	25 Participants n=27 Participants
Age, Categorical >=65 years	23 Participants n=93 Participants	25 Participants n=4 Participants	48 Participants n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Male	33 Participants n=93 Participants	31 Participants n=4 Participants	64 Participants n=27 Participants
Region of Enrollment United States	36 participants n=93 Participants	37 participants n=4 Participants	73 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months post therapy

Population: 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.

All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus

Outcome measures

Measure	Endoscopic Mucosal Resection n=25 Participants Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.	Photodynamic Therapy n=13 Participants Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.	Photodynamic Therapy FISH POSITIVE FISH cytology results were positive prior to therapy	Photodynamic Therapy FISH NEGATIVE FISH cytology results prior to therapy were negative
Level of Dysplasia on Histology at 12 Months Decreases in dysplasia from enrollment	10 paricipants	11 paricipants	—	—
Level of Dysplasia on Histology at 12 Months No improvement or worsened level of dysplasia	15 paricipants	2 paricipants	—	—

PRIMARY outcome

Timeframe: 12 months post therapy

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

Outcome measures

Measure	Endoscopic Mucosal Resection n=11 Participants Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.	Photodynamic Therapy n=13 Participants Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.	Photodynamic Therapy FISH POSITIVE n=8 Participants FISH cytology results were positive prior to therapy	Photodynamic Therapy FISH NEGATIVE n=5 Participants FISH cytology results prior to therapy were negative
Fluorescence In Situ Hybridization (FISH) Markers at 12 Months. no change or worsening of dysplasia post therapy	4 participants	5 participants	2 participants	0 participants
Fluorescence In Situ Hybridization (FISH) Markers at 12 Months. Decrease level of dysplasia post therapy	7 participants	8 participants	6 participants	5 participants

PRIMARY outcome

Timeframe: end of study

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

Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36

Outcome measures

Measure	Endoscopic Mucosal Resection n=10 Participants Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.	Photodynamic Therapy n=6 Participants Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.	Photodynamic Therapy FISH POSITIVE FISH cytology results were positive prior to therapy	Photodynamic Therapy FISH NEGATIVE FISH cytology results prior to therapy were negative
Change in Quality of Life qaulity of life remained the same of improved	9 participants	6 participants	—	—
Change in Quality of Life decrease in qualify of life	1 participants	0 participants	—	—

Adverse Events

Endoscopic Mucosl Resection

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Photodynamic Therapy

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Endoscopic Mucosl Resection n=36 participants at risk patients will undergo endoscopic mucosal resection at time of endoscopy if indicated	Photodynamic Therapy n=37 participants at risk patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
Renal and urinary disorders Renal failure - Sepsis	0.00% 0/36 • 6 years, 2 months	2.7% 1/37 • Number of events 1 • 6 years, 2 months
Respiratory, thoracic and mediastinal disorders Respitory Failure / Sepsis	0.00% 0/36 • 6 years, 2 months	2.7% 1/37 • Number of events 1 • 6 years, 2 months
Cardiac disorders heart attack resulting in death	2.8% 1/36 • Number of events 1 • 6 years, 2 months	5.4% 2/37 • Number of events 2 • 6 years, 2 months

Other adverse events

Measure	Endoscopic Mucosl Resection n=36 participants at risk patients will undergo endoscopic mucosal resection at time of endoscopy if indicated	Photodynamic Therapy n=37 participants at risk patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
Gastrointestinal disorders Bleeding	2.8% 1/36 • Number of events 1 • 6 years, 2 months	2.7% 1/37 • Number of events 1 • 6 years, 2 months
General disorders Dehydration	2.8% 1/36 • Number of events 1 • 6 years, 2 months	2.7% 1/37 • Number of events 1 • 6 years, 2 months
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/36 • 6 years, 2 months	32.4% 12/37 • Number of events 12 • 6 years, 2 months
Cardiac disorders Atrial fibrilation	2.8% 1/36 • Number of events 1 • 6 years, 2 months	0.00% 0/37 • 6 years, 2 months
Gastrointestinal disorders Pain	— 0/0 • 6 years, 2 months	2.7% 1/37 • Number of events 1 • 6 years, 2 months
Gastrointestinal disorders Dysphagia	0.00% 0/36 • 6 years, 2 months	16.2% 6/37 • Number of events 6 • 6 years, 2 months

Additional Information

Kenneth Wang MD

Mayo Clinic

Phone: 507-255-7495

Email: wang.kenneth@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place