UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009583
Receipt number R000011245
Scientific Title Phase II study of neoadjuvant mFOLFOX6 (+ cetuximab) in patients with resectable pelvic recurrences after rectal cancer surgery
Date of disclosure of the study information 2012/12/25
Last modified on 2015/12/25 13:59:36

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Basic information

Public title

Phase II study of neoadjuvant mFOLFOX6 (+ cetuximab) in patients with resectable pelvic recurrences after rectal cancer surgery

Acronym

Phase II of NAC with mFOLFOX6 (+ Cmab)

Scientific Title

Phase II study of neoadjuvant mFOLFOX6 (+ cetuximab) in patients with resectable pelvic recurrences after rectal cancer surgery

Scientific Title:Acronym

Phase II of NAC with mFOLFOX6 (+ Cmab)

Region

Japan


Condition

Condition

Recurrent rectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of mFOLFOX6+cetuximab therapy (KRAS wild-type) and mFOLFOX therapy (KRAS mutant-type) in patients with recurrent rectal cancer which has resectable pelvic recurrences

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

R0 resection rate

Key secondary outcomes

Disease-free survival
Overall survival
Safety
Response rate
Histological 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 Maneuver

Interventions/Control_1

1)KRAS wild-type: mFOLFOX6 + cetuximab
2)KRAS mutant-type: mFOLFOX6

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)A pelvic recurrence after rectal cancer surgery is proved histologically or diagnosed by an imaging
2)Resectable pelvic recurrence by pre-operative examination
3)No prior FOLFOX therapy
4) Patients with radiotherapy history are included
5) No evidence of distant metastasis
6)Age over 20 years
7)ECOG Performance Status (PS) 0-1
8)Written informed consent
9) Adequate organ function
i)Leucocyte count: more than 3,000, less than 12,000 /mm3
ii)Platelet : more than 100,000 / mm3
iii)Serum total bilirubin : less than 1.5 mg / dl
iv)AST : less than 100 U/l
v) ALT : less than 100 U/l
vi)Serum creatinine : less tahn 1.2 mg / dl

Key exclusion criteria

1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
2) Severe infectious disease
3) Patients who receive steroid continuously are excluded
4) Unstable angina or myocardial infarction within 6 months
5) Interstitial pneumonia or fibroid lung
6) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
7) Those considered inappropriate for participation in this trial.

Target sample size

33


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norio Saito

Organization

National Cancer Center Hospital East

Division name

Colorectal Surgery Division, Dept of Surgical Oncology

Zip code


Address

6-5-1 Kashiwanohara, Kashiwa, Chiba

TEL

0471-33-1111

Email

norsaito@east.ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akihiro Kobayashi

Organization

National Cancer Center Hospital East

Division name

National Colorectal Surgery Division, Dept of Surgical Oncology

Zip code


Address

6-5-1 Kashiwanohara, Kashiwa, Chiba

TEL

0471-33-1111

Homepage URL


Email

akobayas@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



Funding Source

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
大阪府立成人病センター(大阪府)
愛知県がんセンター中央病院(愛知県)
山形県立中央病院(山形県)
新潟県立がんセンター新潟病院(新潟県)
石川県立中央病院(石川県)
四国がんセンター(愛媛県)


Other administrative information

Date of disclosure of the study information

2012 Year 12 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Terminated

Date of protocol fixation

2012 Year 11 Month 08 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 08 Day

Last follow-up date

2018 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 12 Month 19 Day

Last modified on

2015 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011245


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name