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

Stage III Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02628665
• Other study ID #: FirstHenanUST,cancer center
• Status: Recruiting
• Phase: Phase 3
• First received: November 27, 2015
• Last updated: December 10, 2015
• Start date: October 2015
• Est. completion date: December 2019

Study information

• Verified date: October 2015
• Source: The First Affiliated Hospital of Henan University of Science and Technology
• Contact: Shegan Gao, Doctor
• Phone: 18638859977
• Email: gsg112258[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Stage I Esophageal Adenocarcinoma
• Stage I Esophageal Squamous Cell Carcinoma
• Stage II Esophageal Adenocarcinoma
• Stage II Esophageal Squamous Cell Carcinoma
• Stage III Esophageal Adenocarcinoma
• Stage III Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• photosensitizer(photofrin)
photosensitizer(photofrin): 2mg/kg

Device:
• 630 nm laser irradiation (DIOMED)
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Henan University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial remission rate	Photodynamic therapy for 3 months after the review of gastroscope for pathologic examination, to check the response rate	3 months	Yes
Secondary	The recent incidence of adverse reactions	Observe 7-10 days postoperatively in patients with the ratio of pain and difficulty swallowing	7-10 days	Yes