Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| 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:
Device: 630 nm laser irradiation (DIOMED)
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
Other Names:
|
| 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:
Device: 630 nm laser irradiation (DIOMED)
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Partial remission rate [3 months]
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 [7-10 days]
Observe 7-10 days postoperatively in patients with the ratio of pain and difficulty swallowing
Eligibility Criteria
Criteria
Inclusion Criteria:
-
In the esophagus, patients with severe dysplasia and carcinoma in situ
-
The patients have not received the surgery or chemo-radiotherapy.
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Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L, ALT、AST≤2.5N,Cr≤1.5N.
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Performance status score 0-2
Exclusion Criteria:
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pregnant, lactating women
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History of organ transplantation
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The peripheral nervous system disorders
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Severe infection
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Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
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Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
-
Other malignant tumor in recent 5 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | China | 471003 |
Sponsors and Collaborators
- 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: Caihong Dong, 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: 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- FirstHenanUST,cancer center