- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02628665
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Shegan Gao, Doctor
- Phone Number: 18638859977
- Email: gsg112258@163.com
Study Contact Backup
- Name: Tanyou Shan, Master
- Phone Number: 18537976669
- Email: shantanyou@163.com
Study Locations
-
-
Henan
-
Luoyang, Henan, China, 471003
- Recruiting
- The First Affiliated Hospital of Henan University of Science and Technology
-
Contact:
- shegan gao, doctor
- Phone Number: 0379 64811906
- Email: gsg112258@163.com
-
Contact:
- tanyou shan, master
- Phone Number: 0379 64815350
- Email: shantanyou@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
photosensitizer(photofrin): 2mg/kg
Other Names:
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. |
photosensitizer(photofrin): 2mg/kg
Other Names:
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
7-10 days
|
Collaborators and Investigators
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: Xiaozhi Yuan, 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: 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
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Heart Diseases
- Cardiovascular Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Thoracic Neoplasms
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma
- Adenocarcinoma
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
- Heart Neoplasms
- Antineoplastic Agents
- Dermatologic Agents
- Dihematoporphyrin Ether
- Trioxsalen
- Photosensitizing Agents
- Hematoporphyrin Derivative
Other Study ID Numbers
- FirstHenanUST,cancer center
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage III Esophageal Squamous Cell Carcinoma
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WithdrawnClinical Stage III Esophageal Adenocarcinoma AJCC v8 | Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8 | Pathologic Stage III Esophageal Adenocarcinoma AJCC v8 | Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8 | Pathologic Stage IIIA Esophageal Adenocarcinoma... and other conditionsUnited States
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Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingStage III Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer... and other conditionsUnited States
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Fujian Medical University Union HospitalNot yet recruitingEsophageal Squamous Cell Carcinoma Thoracic Stage II | Esophageal Squamous Cell Carcinoma Thoracic Stage III | Esophageal Squamous Cell Carcinoma Thoracic Stage IVChina
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The First Affiliated Hospital of Henan University...Luoyang Central Hospital; Nanyang Central Hospital; Sanmenxia Central Hospital; Military 150 Hospital and other collaboratorsActive, not recruitingStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
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The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
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Shanghai Zhongshan HospitalZhejiang Cancer Hospital; Sun Yat-sen University; Cancer Institute and Hospital... and other collaboratorsRecruitingEsophageal Squamous Cell Carcinoma Stage II | Esophageal Squamous Cell Carcinoma Stage IIIChina
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The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
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National Cancer Institute (NCI)Active, not recruitingClinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Unresectable Gastroesophageal Junction Adenocarcinoma | Metastatic Malignant Neoplasm in the Brain and other conditionsUnited States
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The First Affiliated Hospital of Henan University...CompletedMegestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With ChemoradiotherapyStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
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