UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000244 |
|---|---|
| Receipt number | R000000307 |
| Scientific Title | Phase II study of salvage photodynamic therapy for local failure after definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma |
| Date of disclosure of the study information | 2005/09/22 |
| Last modified on | 2005/09/21 00:18:02 |
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Basic information
Public title
Phase II study of salvage photodynamic therapy for local failure after definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma
Acronym
Phase II study of salvage PDT for esophageal carcinoma
Scientific Title
Phase II study of salvage photodynamic therapy for local failure after definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma
Scientific Title:Acronym
Phase II study of salvage PDT for esophageal carcinoma
Region
| Japan |
Condition
Condition
esophageal squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of salvage photodynamic therapy for local failure after definitive chemoradiotherapy for esophageal squamous cell carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Complete response rate of primary site
Key secondary outcomes
Occurence rate of adverse event
Progression free survival
Overall survival
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 | Maneuver |
Interventions/Control_1
Photodynamic therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with esophageal squamous cell carcinoma who were treated with defenitive chemoradiotherapy
2) Patients` refusal of salvage surgery
3) assessed cancerous lesion limited within the submucosal layer by EUS
4) histolical confirmation of squamous cell carcinoma from the lesion
5) Performance status(ECOG): 0, 1, 2
6) Written informed consent
7) adequate organ function, defined as; WBC; 3000-12000/mm3, platelet count; >100000/mm3, serum creatinine level <1.5mg/dl, serum bilirubin level<2.0mg/dl, serum transaminase<100IU/l
Key exclusion criteria
1) No other active malignancy
2) No other severe medical conditions
3) Patients who are suffered systemic infection
4) Patients who cannot keep shading
5) Lesions were judged within mucosal laiyer, and can be treated with EMR
6) Lesions were assessed as T4 before CRT.
7) clinically defined distant or lymph node metastasis by computed tomography and endoscopic ultrasound (EUS) before PDT
8) Patients with porphyria
9) Lesions were not completely evaluated because of stenosis after CRT
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Muto |
Organization
National Cancer Center Hospital East
Division name
Division of digestive endoscopy and GI oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Yano |
Organization
National Cancer Center Hospital East
Division name
Division of digestive endoscopy and GI oncology
Zip code
Address
TEL
Homepage URL
toyano@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 09 | Month | 22 | 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
Date of protocol fixation
| 2005 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 21 | Day |
Last modified on
| 2005 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000307
