UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010639
Receipt number R000012444
Scientific Title Phase I study of TS-1+irinotecan+cetuximab as the first-line therapy in patients with KRAS wild-type metastatic colorectal cancer
Date of disclosure of the study information 2013/05/07
Last modified on 2019/03/08 09:58:11

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Basic information

Public title

Phase I study of TS-1+irinotecan+cetuximab as the first-line therapy in patients with KRAS wild-type metastatic colorectal cancer

Acronym

JACCRO CC-10 study

Scientific Title

Phase I study of TS-1+irinotecan+cetuximab as the first-line therapy in patients with KRAS wild-type metastatic colorectal cancer

Scientific Title:Acronym

JACCRO CC-10 study

Region

Japan


Condition

Condition

metastatic colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determin MTD and RD of TS-1 + irinotecan + cetuximab as the first-line therapy in patients with KRAS wild-type metastatic colorectal cancer

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Recommended Dose

Key secondary outcomes

Safety
Response Rate


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

Interventions/Control_1

Cetuximab 400mg/m2 Day1, 250mg/m2 Day 8, 15
Irinotecan 100-150mg/m2/Day1
S-1 80-120mg/day Day1-14

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) Patients with histologically proven colorectal cancer
(2) KRAS wild type
(3) Presence of evaluable lesion
(4) No prior chmeotherapy or radiotherapy for unresectable primary tumor, metastases and lymphnode metastases. No prior therapy including surgery for reccurent lesions that should be the first relapse after surgery for primary or metastases tumors.
(5) ECOG performance status 0-1
(6) Age 20 years or older
(7) Life expectancy of 3 yeras or longer
(8) Oral food intake possible
(9) Patients have enough organ function for study treatment within 14 days before enrollment
(10) Written informed consent.

Key exclusion criteria

1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval.
2) Symptomatic brain metastases
3) Severe infectious disease.
4) Comorbidity or history of interstitial lung disease or pulmonary fibrosis.
5) Comorbidity or history of severe heart disease.
6) Sensory alteration or paresthesia interfering with function.
7) Large quantity of pleural, abdominal or cardiac effusion.
8) Severe comorbidity (renal failure, liver failure, hypertension, etc.)
9) Prior radiotherapy for primary or metastases tumors.
10) Men/Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test.
11) Any other cases who are regarded as inadequate for sydy enrollment by investigators.

Target sample size

16


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Wataru Ichikawa

Organization

National Defense Medical College Hospital

Division name

Department of Clinical oncology

Zip code


Address

3-2 Namiki, Tokorozawa-shi, Saitama 359-8513, Japan

TEL

04-2995-1511

Email

wataru@ndmc.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masashi

Organization

Japan Clinical Cancer Research Organization

Division name

Office

Zip code


Address

1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan

TEL

03-5579-9882

Homepage URL


Email

jaccro@jaccro.or.jp


Sponsor or person

Institute

Japan Clinical Cancer Research Organization

Institute

Department

Personal name



Funding Source

Organization

Japan Clinical Cancer Research Organization

Organization

Division

Category of Funding Organization

Non profit foundation

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



Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 07 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2013 Year 04 Month 23 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 07 Day

Last follow-up date

2014 Year 06 Month 30 Day

Date of closure to data entry

2014 Year 06 Month 30 Day

Date trial data considered complete

2014 Year 07 Month 23 Day

Date analysis concluded

2014 Year 08 Month 18 Day


Other

Other related information



Management information

Registered date

2013 Year 05 Month 03 Day

Last modified on

2019 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012444


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name