UMIN-CTR Clinical Trial

Public title

Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment in patients with metastatic colorectal cancer in Japan

Acronym

Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment for metastatic CRC in Japan (PaFF-J)

Scientific Title

Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment in patients with metastatic colorectal cancer in Japan

Scientific Title:Acronym

Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment for metastatic CRC in Japan (PaFF-J)

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of panitumumab with FOLFOX or FOLFIRI as 1st line treatment in patients with KRAS wild type, metastatic colorectal cancer in Japan.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Overall response rate (ORR)

Key secondary outcomes

- Safety
- Progression free survival (PFS)
- Overall survival (OS)
- Time to progression (TTP)
- Time to treatment failure (TTF)
- Disease control rate
- R0-resection rate
- Histological investigation of the post-treatment liver tissues
- Correlation between clinico-pathological factors and efficacy

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

Interventions/Control_1

The investigators choose the treatment A or Barbitrarily.
A: FOLFOX + panitumumab
B: FOLFIRI + panitumumab
Repeat every 14 days until meeting the withdrawal criteria.

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Coloretal cancer (adenocarcinoma)
2) Unresectable
3) KRAS wild type
4) Age: 20-80 years old
5) ECOG performance status: 0-1
6) >=1 measurable lesion (at <=30 days prior to enrollment)
7) No prior chemotherapy and radiation thrpy (ex. adjuvant chmotherpy completed <=180 days prior to enrollmet)
8) Adequate organ functions as listed below (at <=14 days prior to enrollment)
i) WBC: 3,000/mm3 to 12,000/mm3
ii) Neutrophl: >=1,500/mm3
iii) Plt: >=100,000/mm3
iv) Hb: >=9.0g/dL
v) T-Bil: <=1.5mg/dL
vi) AST(GOT): <=100*IU/L
vii) ALT(GPT): <=100*IU/L
*patients with liver metastas: <=200IU/L
viii) Creatinine: <=1.2mg/dL
9) Expected survival >=3 months
10) Written informed concent

Key exclusion criteria

1) Prior severe drug allergy
2) Synchronous and/or metachronous multiple cancers
3) Severe bowel stenosis by the primary tumor (ex. after colostomy)
4) Prior adjuvant chemotherapy with oxaliplatin containing regimen
5) Surgical procedure within 28 days prior to enrollment (ex. venous reservoirs implant, colostomy)
6) Severe comorbidity:
- severe pulmonary dysfunction
- Uncontrolled DM
- Uncontrolled HT
- severe cardiovascular disease
- Cirrhosis and liver failure
- Renal failure
7) Sensory neuropathy
8) Severe diarrhea
9) Active infection
10) Symptomatic pleural effusion or ascites
11) Contraindications to 5-FU, l-LV, panitumumab, L-OHP or CPT-11
12) Concerning pregnancy
13) The investigator considers not suitable for the study

Target sample size

165

Name of lead principal investigator

1st name
Middle name
Last name	Kenichi Sugihara, M.D., PhD

Organization

Tokyo Medical and Dental University, Graduate School

Division name

Dept. of Surgical Oncology

Zip code

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan

TEL

03-5803-5261

Email

k-sugi.srg2@tmd.ac.jp

Name of contact person

1st name
Middle name
Last name	Kenichi Sugihara, M.D., PhD

Organization

Tokyo Medical and Dental University, Graduate School

Division name

Dept. of Surgical Oncology

Zip code

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan

TEL

03-5803-5261

Homepage URL

http://www.ibri-kobe.org/

Email

k-sugi.srg2@tmd.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Foundation for Biomedical Research and Innovation

Organization

Division

Category of Funding Organization

Non profit foundation

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

Institutions

Date of disclosure of the study information

2011

Year

02

Month

26

Day

URL releasing protocol

Publication of results

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

2011

Year

01

Month

28

Day

Date of IRB

Anticipated trial start date

2011

Year

05

Month

01

Day

Last follow-up date

2015

Year

04

Month

01

Day

Date of closure to data entry

2015

Year

10

Month

28

Day

Date trial data considered complete

2015

Year

12

Month

23

Day

Date analysis concluded

Other related information

Registered date

2011

Year

02

Month

01

Day

Last modified on

2017

Year

02

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005934