UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405EPG for patients with local failure after chemoradiotherapy for esophageal cancer
Title of the study (Brief title)	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	Manabu Muto
Organization	Graduate School of Medicine Kyoto University
Division name	Department of Therapeutic Oncology
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	Hiroi Kasai
Organization	Kyoto University Hospital
Division name	Institute for Advancement of Clinical and Translational Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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