UMIN-ICDS Clinical Trial

Public title

Exploratory clinical trial to evaluate the feasibility and efficacy of conversion surgery after systemic chemotherapy followed by carbon ion radiotherapy against locally advanced unresectable pancreatic cancer

Acronym

Yu-PANC-02

Scientific Title

Exploratory clinical trial to evaluate the feasibility and efficacy of conversion surgery after systemic chemotherapy followed by carbon ion radiotherapy against locally advanced unresectable pancreatic cancer

Scientific Title:Acronym

Yu-PANC-02

Region

Japan

Condition

Initially locally advanced unresectable pancreatic cancer after chemotherapy followed by carbon-ion radiotherapy with favorable response

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate feasibility and efficacy of conversion surgery for initially locally advanced unresectable pancreatic cancer after chemotherapy followed by carbon-ion radiotherapy with favorable response.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Postoperative morbidity rate with severe complication and mortality rate

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

Maneuver

Interventions/Control_1

Curative resection for pancreatic cancer

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

18

years-old

<=

Age-upper limit

79

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Pre-treatment histological or cytological confirmation of
malignancy.
2. Radiologically diagnosed as pancreatic ductal adenocarcinoma before treatment.
3. Unresectable locally-advanced (UR-LA) or Borderline resectable with arterial abutment (BR-A), confirmed by CT-imaging before treatment.
4. No obvious distant metastatic findings.
5. More than 4 months chemotherapy for pancreatic cancer.
6. Carbon ion radiotherapy after chemotherapy described above 5.
7. Disease control after more than 6 months treatment (RECIST=CR, PR, SD).
8. Serum tumor marker decrease after more than 6 months treatment.
9. No distant metastases by staging laparoscopy, including positive peritoneal lavage cytology.
10. Performance status is 0 or 1 (ECOG).
11. No serious comorbidity.
12. No active and ongoing other malignancy.
13. Able to eat orally
14. Written informed consent.

Key exclusion criteria

1. No pre-treatment histological or cytological confirmation of malignancy.
2. Resectable (R) or Borderline resectable without arterial abutment (BR-PV), confirmed by CT-imaging before treatment.
3. Obvious distant metastatic findings.
4. Less than 4 months chemotherapy.
5. No treatment with carbon ion radiotherapy.
6. Without disease control after treatment (RECIST=PD).
7. Serum tumor marker increase after treatment.
8. Distant metastases detected staging laparoscopy after treatment, including positive peritoneal lavage cytology.
9. Performance status is 2 or 3 (ECOG).
10. Serious comorbidity.
11. Active and ongoing other malignancy.
12. Unable to eat orally

Target sample size

25

Name of lead principal investigator

1st name	Motoi
Middle name
Last name	Fuyuhiko

Organization

Yamagata University

Division name

Department of Surgery I

Zip code

990-9585

Address

2-2-2, Iida-Nishi, Yamagata

TEL

023-628-5334

Email

fmotoi@med.id.yamagata-u.ac.jp

Name of contact person

1st name	Motoi
Middle name
Last name	Fuyuhiko

Organization

Yamagata University

Division name

Department of Surgery I

Zip code

990-9585

Address

2-2-2, Iida-Nishi, Yamagata

TEL

023-628-5334

Homepage URL

http://www.surgery1-yamagata.net/index.html

Email

fmotoi@med.id.yamagata-u.ac.jp

Institute

Faculty of Medicine, Yamagata University

Institute

Department

Personal name

Organization

Faculty of Medicine, Yamagata University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The ethic review committee of facluty of medi cine, Yamagata University

Address

2-2-2, Iida-Nishi, Yamagata

Tel

023-633-1122

Email

yu-ikekenkyu@jm.kj.yamagata-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

山形大学医学部附属病院（山形県）

Date of disclosure of the study information

2022

Year

11

Month

08

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

Enrolling by invitation

Date of protocol fixation

2022

Year

10

Month

24

Day

Date of IRB

2022

Year

10

Month

27

Day

Anticipated trial start date

2022

Year

11

Month

08

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

11

Month

08

Day

Last modified on

2022

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055510