UMIN-CTR Clinical Trial

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

Patients with local failure after chemoradiotherapy for esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyoto University Hospital

Institute

Department

Personal name

Organization

MHLW
Kyoto University

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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）

Date of disclosure of the study information

2012

Year

10

Month

25

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2012

Year

10

Month

24

Day

Last modified on

2017

Year

09

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010783