UMIN-CTR Clinical Trial

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

Esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Phase I: Dose limiting toxicity of each laser irradiation level
Phase II: Complete response rate of primary site

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

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

Email

toyano@east.ncc.go.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

Ministry of Health, Labor, and Welfare of Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

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

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)

Date of disclosure of the study information

2010

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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