Clinical trial NCT02628665: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: 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
Lead sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Partial remission rate
timeFrame: 3 months
Secondary outcomes:
measure: The recent incidence of adverse reactions
timeFrame: 7-10 days
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Shegan Gao, Doctor
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Tanyou Shan, Master
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Caihong Dong, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Xiaozhi Yuan, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Lin Guo, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Lijuan Zhang, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Gailin Wang, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.