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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: The First Affiliated Hospital of Henan University of Science and Technology

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Henan University of Science and Technology

Dates:
Date Received: November 27, 2015
Date Started: October 2015
Date Completion: December 2019
Last Updated: December 10, 2015
Last Verified: October 2015