UMIN-CTR Clinical Trial

Public title

Randomized phase II study of CPT-11 plus TS-1 plus Cetuximab for advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type (OGSG 0901)

Acronym

OGSG 0901

Scientific Title

Randomized phase II study of CPT-11 plus TS-1 plus Cetuximab for advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type (OGSG 0901)

Scientific Title:Acronym

OGSG 0901

Region

Japan

Condition

advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To confirm the feasibility and effectiveness of CPT-11 plus TS-1 plus Cetuximab for advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Response Rate(RECIST)

Key secondary outcomes

1)survival time
2)Time to progression
3)Ratio controling the tumor
4)Adverse events
5)Incidence of skin illness in grade 2-3

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

Interventions/Control_1

<Administration schedule>
One couese takes 28 days.
TS-1:TS-1(14days),interval(14days)
CPT-11:Day1,Day15,Day29
Cetuximab:Day1,Day8,Day15,Day22,Day29
TS-1:80mg/m2
CPT-11:100mg/m2
Cetuximab:only one couse (400mg/m2)
two couse after (250mg/m2)

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

1) Histologically proven colon cancer or rectal cancer
2) genetically proven KRAS wild type of the tumor tissue
3) with measurable lesions for RECIST criteria
4) Patients with tumor resistant to oxaliplatin after one or more courses of oxaliplatin treatment and without treatments including CPT-11 and/or Cetuximab
5) patients older than 20 years
6) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1, 2 or less.
7) A predicted life expectancy of at least 3 months.
8) with prior chemotherapy completed before more than 20 days
9) with normal function of the important organs
10) Ability of oral intake
11) Written informed consent to participate in this study

Key exclusion criteria

1) with treatments including CPT-11 and/or Cetuximab
2) with active double cancers
3) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc.
4) Infectious disease
5) Diarrhea (watery stools)
6) with obstruction or disorder on digestive tract due to peritoneal metastasis
7) with ascites and/or pleural fluid
8) History of serious drug hypersensitivity
9) Undergoing anti-fungal treatment with fluorocytosine, or atazanavir sulfate.
10) Found to have fresh gastrointestinal bleeding that requires repeated transfusion.
11) With liver cirrhosis or jaundice.
12) patients undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment.
13) having heart disease, such as ischemic heart disease or an arrhythmia, which require treatment.
14) With diabetes that is difficult to control.
15) With central nervous system metastasis
16) women pregnant, breast-feeding, or who wish pregnancy
17) Any other patient whom the physician in charge of the study judges to be unsuitable

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	sakai daisuke

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Dpt.Tumor psychiatry

Zip code

Address

1-3-3, nakamichi,higashinari-ku,osaka

TEL

06-6972-1181

Email

Name of contact person

1st name
Middle name
Last name

Organization

Sakai City Hospital

Division name

Dpt.Surgery

Zip code

Address

TEL

Homepage URL

Email

Institute

Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

Institute

Department

Personal name

Organization

Osaka Clinical Study Supporting Organization

Organization

Division

Category of Funding Organization

Self funding

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

Date of disclosure of the study information

2009

Year

10

Month

31

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

2009

Year

10

Month

26

Day

Date of IRB

Anticipated trial start date

2009

Year

10

Month

01

Day

Last follow-up date

2015

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

10

Month

31

Day

Last modified on

2021

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003288