UMIN-CTR Clinical Trial

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
Email

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
Email	toyano@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000307

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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