Stage I Esophageal AdenocarcinomaPhase 3NCT02628665
Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer
A Phase 3 study testing photosensitizer(photofrin) and 630 nm laser irradiation (DIOMED) in people with Stage I Esophageal Adenocarcinoma and Stage II Esophageal Adenocarcinoma, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stage I Esophageal Adenocarcinoma, Stage II Esophageal Adenocarcinoma, Stage III Esophageal Adenocarcinoma
- What is being tested?
- photosensitizer(photofrin) and 630 nm laser irradiation (DIOMED)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
shegan gao, doctor, 0379 64811906, gsg112258@163.com
tanyou shan, master, 0379 64815350, shantanyou@163.com
About this study
Official title: Two-arm Phase III Trial Comparing Different Time of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer
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.
Read the 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.
- 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
- Being tested
- photosensitizer(photofrin), 630 nm laser irradiation (DIOMED)
- Medical subject headings
- Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photosensitizer(photofrin)Drug
Also called photofrin
photosensitizer(photofrin): 2mg/kg
630 nm laser irradiation (DIOMED)Device
Also called DIOMED
630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
| Study group | Role | What they receive |
|---|---|---|
| 24 to 48 hours group | Experimental | 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. Receives: Drug: photosensitizer(photofrin); Device: 630 nm laser irradiation (DIOMED) |
| 48 to 72 hours group | Active comparator | 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. Receives: Drug: photosensitizer(photofrin); Device: 630 nm laser irradiation (DIOMED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial remission rate
Photodynamic therapy for 3 months after the review of gastroscope for pathologic examination, to check the response rate
Measured: 3 months
Secondary outcomes (1)
The recent incidence of adverse reactions
Observe 7-10 days postoperatively in patients with the ratio of pain and difficulty swallowing
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stage I Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shegan Gao, Doctor, Study chair, The First Affiliated Hospital of Henan University of Science and TechnologyTanyou Shan, Master, Study director, The First Affiliated Hospital of Henan University of Science and TechnologyCaihong Dong, Master, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyXiaozhi Yuan, Master, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyLin Guo, Bachelor, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyLijuan Zhang, Bachelor, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyGailin Wang, Bachelor, Principal investigator, The First Affiliated Hospital of Henan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628665
- Sponsor's protocol ID
- FirstHenanUST,cancer center
- Status last verified
- Oct 2015
- First submitted
- 27 Nov 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22334351Yano 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.
PubMed 22024814
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-arm Phase III Trial Comparing Different Time of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer
- ClinicalTrials.gov ID
- NCT02628665
- Acronym / sponsor ID
- FirstHenanUST,cancer center
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 to 48 hours group | Experimental | Drug: photosensitizer(photofrin), Device: 630 nm laser irradiation (DIOMED)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. |
| 48 to 72 hours group | Active comparator | Drug: photosensitizer(photofrin), Device: 630 nm laser irradiation (DIOMED)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photosensitizer(photofrin)Also: photofrinphotosensitizer(photofrin): 2mg/kg | Drug | 24 to 48 hours group, 48 to 72 hours group |
| 630 nm laser irradiation (DIOMED)Also: DIOMED630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds. | Device | 24 to 48 hours group, 48 to 72 hours group |
Primary outcome
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
1 secondary outcome
The recent incidence of adverse reactions
Time frame: 7-10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Background: PubMed 22334351Lindenmann 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.
- Background: PubMed 22024814Yano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shegan Gao, Doctor study chair
The First Affiliated Hospital of Henan University of Science and Technology
Tanyou Shan, Master study director
The First Affiliated Hospital of Henan University of Science and Technology
Caihong Dong, Master principal investigator
The First Affiliated Hospital of Henan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing photosensitizer(photofrin) and 630 nm laser irradiation (DIOMED) in people with Stage I Esophageal Adenocarcinoma and Stage II Esophageal Adenocarcinoma, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shegan Gao, Doctor (18638859977, gsg112258@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial remission rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02628665, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.