Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer
Two-arm Phase III Trial Comparing Different Time of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 27, 2015
CompletedFirst Posted
Study publicly available on registry
December 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedDecember 11, 2015
October 1, 2015
2 years
November 27, 2015
December 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Partial remission rate
Photodynamic therapy for 3 months after the review of gastroscope for pathologic examination, to check the response rate
3 months
Secondary Outcomes (1)
The recent incidence of adverse reactions
7-10 days
Study Arms (2)
24 to 48 hours group
EXPERIMENTALphotosensitizer(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.
48 to 72 hours group
ACTIVE COMPARATORphotosensitizer(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.
Interventions
photosensitizer(photofrin): 2mg/kg
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Related 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.
PMID: 22334351BACKGROUNDYano 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.
PMID: 22024814BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2015
First Posted
December 11, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2017
Study Completion
December 1, 2019
Last Updated
December 11, 2015
Record last verified: 2015-10