Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002935
Status:
COMPLETED
Last Update Posted:
2011-12-23
First Post:
1999-11-01
Brief Title:
Photodynamic Therapy in Treating Patients With Early Esophageal Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase II Study of the Safety and Efficacy of Photodynamic Therapy in Carcinoma in Situ of the Esophagus
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells This may be an effective treatment for esophageal cancer
PURPOSE Phase II trial to study the effectiveness of photodynamic therapy in treating patients with Barretts esophagus who have in situ esophageal cancer
PURPOSE Phase II trial to study the effectiveness of photodynamic therapy in treating patients with Barretts esophagus who have in situ esophageal cancer
Detailed Description:
OBJECTIVES I Evaluate the efficacy of photodynamic therapy PDT using porfimer sodium Photofrin and controlled uniform laser light in patients with carcinoma in situ in Barretts esophagus or severe dysplasia in Barretts esophagus II Evaluate the safety of the treatment on this patient
OUTLINE This is a noncomparative study PDT consists of IV porfimer sodium followed 40-50 hours later by laser red light delivered by optic fibers passed through the biopsy channel of an endoscope Retreatment if necessary consists of up to 3 injections at least 30 days apart and up to 6 laser light treatments with a maximum of 2 following each injection Patients are followed monthly for 4 months and then periodically for at least 5 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
OUTLINE This is a noncomparative study PDT consists of IV porfimer sodium followed 40-50 hours later by laser red light delivered by optic fibers passed through the biopsy channel of an endoscope Retreatment if necessary consists of up to 3 injections at least 30 days apart and up to 6 laser light treatments with a maximum of 2 following each injection Patients are followed monthly for 4 months and then periodically for at least 5 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-DS-93-23 | None | None | None |