UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003970 |
|---|---|
| Receipt number | R000004788 |
| Scientific Title | Phase I/II study of photodynamic therapy (PDT) using talaporfin sodium and diode laser for local failure after chemoradiotherapy (CRT) or radiotherapy (RT) for patients with esophageal cancer |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2011/07/08 22:26:12 |
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Basic information
Public title
Phase I/II study of photodynamic therapy (PDT) using talaporfin sodium and diode laser for local failure after chemoradiotherapy (CRT) or radiotherapy (RT) for patients with esophageal cancer
Acronym
Phase I/II study of PDT using talaporfin sodium and diode laser after CRT for esophageal cancer
Scientific Title
Phase I/II study of photodynamic therapy (PDT) using talaporfin sodium and diode laser for local failure after chemoradiotherapy (CRT) or radiotherapy (RT) for patients with esophageal cancer
Scientific Title:Acronym
Phase I/II study of PDT using talaporfin sodium and diode laser after CRT for esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I
To determine the recommended laser irradiation dose of PDT using talaporfin sodium and diode laser for local failure after CRT or RT for esophageal cancer
Phase II
To evaluate the efficacy and the toxicity of PDT with recommended laser irradiation dose
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: Dose limiting toxicity of each laser irradiation level
Phase II: Complete response rate of primary site
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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
PDT using talaporfin sodium and diode laser
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
Phase I
1) Esophageal cancer which was treated with radiotherapy or chemoradiotherapy (>=50Gy)
2) Patients with definitive local failure who refuse salvage surgery or have physical complications that would have made surgery intolerable.
3) local failure was limited within uT2
4) local failure lesion do not involve to cervical esophagus
5)length of failure lesion is 3cm or less, and circumference is 1/2 or less of the lumen
6) Within two lesions
7) absent of distant or lymph node metastasis requiring systemic chemotherapy
8) endoscopically proved local failure, and histologically confirmation is not essential.
9) Performance status (ECOG) of 0 to 2
10) adequate organ functions
11) Written informed consent
Phase II
1) Esophageal cancer which was treated with radiotherapy or chemoradiotherapy (>=50Gy)
2) Patients with histologically confirmed local failure who refuse salvage surgery or have physical complications that would have made surgery intolerable.
3) local failure lesion staging limited within uT2
4) local failure lesion do not involve to cervical esophagus
5)length of failure lesion is 3cm or less, and circumference is 1/2 or less of the lumen
6) Within two lesions
7) absent of distant or lymph node metastasis
9) Performance status (ECOG) of 0 to 2
10) adequate organ functions
11) Written informed consent
Key exclusion criteria
Phase I
1) severe complication as follows; uncontrollable hypertension, uncontrollable diabetes mellitus, severe liver cirrhosis, severe cardiovascular disease (myocardial infarction, angina pectoris, congestive heart failure)
2) systemic infection
3) inability to keep sun shade
4) additional PDT just after salvage EMR for local failure after CRT or RT
5) baseline T4 to Aorta
6) known porphyria
7) photosensitive disorder
8) prior PDT using talaporfin sodium, prior PDT using porfimer sodium within 3 months.
9) woman during pregnancy or breast-feeding, patient who refuse to prevent pregnancy
10) patient judged as inadequate to entry by each investigator
Phase II
1) other active malignancies except for early gastrointestinal cancer curable with endoscopic treatment
2) severe complication as follows; uncontrollable hypertension, uncontrollable diabetes mellitus, severe liver cirrhosis, severe cardiovascular disease (myocardial infarction, angina pectoris, congestive heart failure)
3) systemic infection
4) inability to keep sun shade
5) additional PDT just after salvage EMR for local failure after CRT or RT
6) baseline T4 to Aorta
7) known porphyria
8) photosensitive disorder
9) prior PDT using talaporfin sodium or porfimer sodium.
10) woman during pregnancy or breast-feeding, patient who refuse to prevent pregnancy
11) patient judged as inadequate to entry by each investigator
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Muto |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and GI Oncology
Zip code
Address
TEL
Homepage URL
toyano@east.ncc.go.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor, and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学病院（京都府） Kyoto University hospital (Kyoto)
国立がん研究センター東病院（千葉県）National Cancer Center Hospital East (Chiba)
獨協医科大学病院（栃木県） Dokkyou University hospital (Tochigi)
静岡県立静岡がんセンター（静岡県） Shizuoka Cancer Center (Shizuoka)
大阪府立成人病センター（大阪府） Osaka Medical Center for Cancer and
Cardiovascular Diseases (Osaka)
兵庫県立がんセンター（兵庫県） Hyogo Cancer Center (Hyogo)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 30 | Day |
Last modified on
| 2011 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004788
