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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009184
Receipt No. R000010783
Scientific Title Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405EPG for patients with local failure after chemoradiotherapy for esophageal cancer
Date of disclosure of the study information 2012/10/25
Last modified on 2017/09/06

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Basic information
Public title Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405EPG for patients with local failure after chemoradiotherapy for esophageal cancer
Acronym Investigator initiated clinical trial of PDT for esophageal cancer
Scientific Title Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405EPG for patients with local failure after chemoradiotherapy for esophageal cancer
Scientific Title:Acronym Investigator initiated clinical trial of PDT for esophageal cancer
Region
Japan

Condition
Condition Patients with local failure after chemoradiotherapy for esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of photodynamic therapy using ME2906 and PNL6405EPG for patients with local failure after chemoradiotherapy of radiotherapy alone for esophageal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Local complete response
Key secondary outcomes (1)Confirmed local complete response
(2)Local-progression free survival, progression free survival, Local-time to treatment failure, overall survival
(3)Lesion local-complete response
(4)Lesion confirmed local-complete response

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 One hundred milligrams of talaporfin sodium are dissolved in 4 mL of saline, and a 40 mg/m2 dose is slowly injected intravenously.
Four to 6 hours after administration of talaporfin sodium, the local failure lesion is irradiated with diode laser at a 664 nm wave- length.
The fluence is set at 100 J/cm2 with a fixed fluence rate of 150 mW/cm2. No limitation of tatal irradiation dose.
If the definitive residual lesion is exsisted with endoscopic observation at next day, additional laser irradiation is performed on the next day as a second session without re-administration of talaporfin sodium .
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Local failure after CRT or RT(>= 50 Gy) for esophageal cancer
2) The duration from the last day of prior treatment was one week or more. Any prior treatment are permitted, except for PDT using talaporfin sodium
3) With local failure lesions which are histologically proven carcinoma by biopsy specimen, and patients do not hope to treat with salvage esophagectomy or lack of tolerability for salvage esophagectomy
4) local failure lesions which are judged as it is impossible to achieve curative resection with salvage EMR or ESD
5) local failed lesions that were not involved in the cervical esophagus
6) local failed lesions limited within the muscularis propria (T2)
7) longitudinal lesion length of shorter than 3 cm and less than one half the circumference of the lumen
8) no more than 2 failure lesions;
9) age ; 20,
10) Eastern Cooperative Oncology Group performance status; 2;
11) adequate bone marrow function (white blood cell count ;2000/mm3
, hemoglobin >8.0 g/dL, platelet count ;75,000/mm3), and liver function (serum total bilirubin level ; 3.0 mg/dL, both alanine aminotransferase and aspartate aminotransferase ; 100 IU/L)
12) provision of written informed consent.
Key exclusion criteria 1) patients with lymph node or distant metastasis with indication for systemic chemotherapy
2) active malignancy at other organs, except for cancer which are unnecessary to be treated with systemic treatment within 6 months, or curable cancer with local treatment
3) significant cardiovascular diseases (uncontrolled hypertension, myocardial infarction, unstable angina, congestive heart failure), uncontrolled diabetes mellitus, or severe liver cirrhosis, severe renal failure
4)severe systemic infection
5) judged by investigator that inability to obey the sun shade restrictions
6) baseline lesions before CRT or RT judged to involve the aorta
7) porphyria
8) additional PDT just after salvage endoscopic mucosal resection or endoscopic submucosal dissection for local failures
9) preexisting of sun photosensitivity
10) history of treatment with PDT using porfimer sodium or talaporfin sodium
11) pregnant or nursed women, or unwillingness to use of contraception
12) Severe bleeding or shock status
13) tendency of hemorrhage
14) participating in other clinical trials or within 3 months after retirement of prior clinical trial,
15) judged by investigator that enrollment was inappropriate for the patient.

Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization Graduate School of Medicine Kyoto University
Division name Department of Therapeutic Oncology
Zip code
Address 54 Kawaharacho, Shogoin, Sakyoku, Kyoto, 606-8507 Japan
TEL 075-751-3111
Email pdt_office@ml.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroi Kasai
Organization Kyoto University Hospital
Division name Institute for Advancement of Clinical and Translational Science
Zip code
Address 54 Kawaharacho, Shogoin, Sakyoku, Kyoto, 606-8507 Japan
TEL 075-751-4722
Homepage URL
Email pdt_office@ml.kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization MHLW
Kyoto University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW 1994年12月22日 第4回/2012年9月25日 第1回

Institutions
Institutions 京都大学医学部附属病院(京都府)
国立がん研究センター東病院(千葉県)
名古屋市立大学病院(愛知県)
兵庫県立がんセンター(兵庫県)
大阪府立成人病センター(大阪府)
長崎大学病院(長崎県)
静岡県立静岡がんセンター(静岡県)

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 09 Day
Last follow-up date
2017 Year 06 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 24 Day
Last modified on
2017 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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