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Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer

Primary Purpose

Stage I Esophageal Adenocarcinoma, Stage II Esophageal Adenocarcinoma, Stage III Esophageal Adenocarcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
photosensitizer(photofrin)
630 nm laser irradiation (DIOMED)
Sponsored by
The First Affiliated Hospital of Henan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I Esophageal Adenocarcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • In the esophagus, patients with severe dysplasia and carcinoma in situ
  • The patients have not received the surgery or chemo-radiotherapy.
  • Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L, ALT、AST≤2.5*N,Cr≤1.5*N.
  • Performance status score 0-2

Exclusion Criteria:

  • pregnant, lactating women
  • History of organ transplantation
  • The peripheral nervous system disorders
  • Severe infection
  • Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
  • Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
  • Other malignant tumor in recent 5 years.

Sites / Locations

  • The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

24 to 48 hours group

48 to 72 hours group

Arm Description

photosensitizer(photofrin): 2mg/kg, Diomed Surgical Diode Laser:400mv/cm irridiation 750 seconds, 24 to 48 hours: The injection of photosensitizer(photofrin) 24 to 48 hours light irradiation power. 630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.

photosensitizer(photofrin): 2mg/kg, Diomed Surgical Diode Laser:400mv/cm irridiation 750 seconds, 48 to 72 hours: The injection of photosensitizer(photofrin) 48 to 72 hours light irradiation power. 630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.

Outcomes

Primary Outcome Measures

Partial remission rate
Photodynamic therapy for 3 months after the review of gastroscope for pathologic examination, to check the response rate

Secondary Outcome Measures

The recent incidence of adverse reactions
Observe 7-10 days postoperatively in patients with the ratio of pain and difficulty swallowing

Full Information

First Posted
November 27, 2015
Last Updated
December 10, 2015
Sponsor
The First Affiliated Hospital of Henan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02628665
Brief Title
Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer
Official Title
Two-arm Phase III Trial Comparing Different Time of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Henan University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The therapy of photofrin PDT was effective in improving life quality of patients with advanced esophageal and/or gastric cardiac cancer and the time optimizing for employing laser irradiation was of great importance.The purpose of this study is to evaluate the clinical efficacy and adverse effects of Photodynamic Therapy (PDT) on esophageal and/or gastric cardiac cancer during different time after inject photofrin.
Detailed Description
The investigators plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma or gastric cardia adenocarcinoma from the Oct.2015. The patients will be divided into two groups. Group 1: Following intravenous administration of photofrin at dose of 2 mg/kg.b.w. as the photosensitizer, 630 nm laser irradiation (DIOMED) with 400 mW/cm was applied on each part of tumor for 750 seconds through cylinder diffusing quartz fibers localizing in the biopsy channel of a flexible endoscope at 24th. Group 2: Following intravenous administration of photofrin at dose of 2 mg/kg.b.w. as the photosensitizer, 630 nm laser irradiation (DIOMED) with 400 mW/cm was applied on each part of tumor for 750 seconds through cylinder diffusing quartz fibers localizing in the biopsy channel of a flexible endoscope at 48th.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Esophageal Adenocarcinoma, Stage II Esophageal Adenocarcinoma, Stage III Esophageal Adenocarcinoma, Stage I Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma, Stage III Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
24 to 48 hours group
Arm Type
Experimental
Arm Description
photosensitizer(photofrin): 2mg/kg, Diomed Surgical Diode Laser:400mv/cm irridiation 750 seconds, 24 to 48 hours: The injection of photosensitizer(photofrin) 24 to 48 hours light irradiation power. 630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
Arm Title
48 to 72 hours group
Arm Type
Active Comparator
Arm Description
photosensitizer(photofrin): 2mg/kg, Diomed Surgical Diode Laser:400mv/cm irridiation 750 seconds, 48 to 72 hours: The injection of photosensitizer(photofrin) 48 to 72 hours light irradiation power. 630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
Intervention Type
Drug
Intervention Name(s)
photosensitizer(photofrin)
Other Intervention Name(s)
photofrin
Intervention Description
photosensitizer(photofrin): 2mg/kg
Intervention Type
Device
Intervention Name(s)
630 nm laser irradiation (DIOMED)
Other Intervention Name(s)
DIOMED
Intervention Description
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
Primary Outcome Measure Information:
Title
Partial remission rate
Description
Photodynamic therapy for 3 months after the review of gastroscope for pathologic examination, to check the response rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The recent incidence of adverse reactions
Description
Observe 7-10 days postoperatively in patients with the ratio of pain and difficulty swallowing
Time Frame
7-10 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In the esophagus, patients with severe dysplasia and carcinoma in situ The patients have not received the surgery or chemo-radiotherapy. Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L, ALT、AST≤2.5*N,Cr≤1.5*N. Performance status score 0-2 Exclusion Criteria: pregnant, lactating women History of organ transplantation The peripheral nervous system disorders Severe infection Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes. Other malignant tumor in recent 5 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shegan Gao, Doctor
Phone
18638859977
Email
gsg112258@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tanyou Shan, Master
Phone
18537976669
Email
shantanyou@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shegan Gao, Doctor
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tanyou Shan, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Caihong Dong, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaozhi Yuan, Master
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lin Guo, Bachelor
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lijuan Zhang, Bachelor
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gailin Wang, Bachelor
Organizational Affiliation
The First Affiliated Hospital of Henan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shegan gao, doctor
Phone
0379 64811906
Email
gsg112258@163.com
First Name & Middle Initial & Last Name & Degree
tanyou shan, master
Phone
0379 64815350
Email
shantanyou@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22334351
Citation
Lindenmann J, Matzi V, Neuboeck N, Anegg U, Baumgartner E, Maier A, Smolle J, Smolle-Juettner FM. Individualized, multimodal palliative treatment of inoperable esophageal cancer: clinical impact of photodynamic therapy resulting in prolonged survival. Lasers Surg Med. 2012 Mar;44(3):189-98. doi: 10.1002/lsm.22006. Epub 2012 Feb 14.
Results Reference
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PubMed Identifier
22024814
Citation
Yano T, Muto M, Minashi K, Iwasaki J, Kojima T, Fuse N, Doi T, Kaneko K, Ohtsu A. Photodynamic therapy as salvage treatment for local failure after chemoradiotherapy in patients with esophageal squamous cell carcinoma: a phase II study. Int J Cancer. 2012 Sep 1;131(5):1228-34. doi: 10.1002/ijc.27320. Epub 2012 Mar 2.
Results Reference
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Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer

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