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

December 10, 2015 updated by: The First Affiliated Hospital of Henan University of Science and Technology

Two-arm Phase III Trial Comparing Different Time of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science And Technology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 24 to 48 hours group

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.
Drug: photosensitizer(photofrin)
photosensitizer(photofrin): 2mg/kg
Other Names:
  • photofrin
Device: 630 nm laser irradiation (DIOMED)
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
Other Names:
  • DIOMED
Active Comparator: 48 to 72 hours group

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.
Drug: photosensitizer(photofrin)
photosensitizer(photofrin): 2mg/kg
Other Names:
  • photofrin
Device: 630 nm laser irradiation (DIOMED)
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
Other Names:
  • DIOMED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial remission rate
Time Frame: 3 months
Photodynamic therapy for 3 months after the review of gastroscope for pathologic examination, to check the response rate
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The recent incidence of adverse reactions
Time Frame: 7-10 days
Observe 7-10 days postoperatively in patients with the ratio of pain and difficulty swallowing
7-10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Investigators

  • Study Chair: Shegan Gao, Doctor, The First Affiliated Hospital of Henan University of Science And Technology
  • Study Director: Tanyou Shan, Master, The First Affiliated Hospital of Henan University of Science And Technology
  • Principal Investigator: Xiaozhi Yuan, Master, The First Affiliated Hospital of Henan University of Science And Technology
  • Principal Investigator: Caihong Dong, Master, The First Affiliated Hospital of Henan University of Science And Technology
  • Principal Investigator: Lin Guo, Bachelor, The First Affiliated Hospital of Henan University of Science And Technology
  • Principal Investigator: Lijuan Zhang, Bachelor, The First Affiliated Hospital of Henan University of Science And Technology
  • Principal Investigator: Gailin Wang, Bachelor, The First Affiliated Hospital of Henan University of Science And Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstHenanUST,cancer center

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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