UMIN-CTR Clinical Trial

Public title

Phase II study of combination therapy with S-1 plus cetuximab in patients with EGFR positive KRAS wild type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine(KSCC0901).

Acronym

Phase II study of 3rd-line therapy with S-1 plus cetuximab in patients with KRAS wild type unresectable colorectal cancer(KSCC0901).

Scientific Title

Phase II study of combination therapy with S-1 plus cetuximab in patients with EGFR positive KRAS wild type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine(KSCC0901).

Scientific Title:Acronym

Phase II study of 3rd-line therapy with S-1 plus cetuximab in patients with KRAS wild type unresectable colorectal cancer(KSCC0901).

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Medicine in general	Gastroenterology	Hematology and clinical oncology
Surgery in general	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of S-1 plus cetuximab combination therapy in patients with EGFR positive KRAS wild type unreseactable advanced/reccurent colorectal cancer, who had documented PD of 5FU based chemotherapy, and had received irinotecan and oxaliplatin.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Progression free survival(PFS)

Key secondary outcomes

ORR, OS, OS from first diagnosis, DCR, TTF, DI, safety, BRAF mutation

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

Cetuximab/S-1 combination therapy
Cetuximab weekly administration 400 mg/m2(day1), 250mg/m2/week(except day1)
S-1 80-120mg/day, PO from day1 to day 28 of each 42 day cycle.

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) Written informed consent
2) Patients who is judged by investigator to be able to receive the protocol therapy
3) Patients with histologically proven colorectal cancer and clinically proven unresectable advanced/recurrent colorectal cancer
4) Presence of measurable lesion judged by enhanced CT (according to the RECIST 1.1)
5) Patients who had previously received on irinotecan, oxaliplatin and fluoropyrimidine.
6) Patients who had documented PD of 5FU based chemotherapy.
7) EGFR expression in the primary or metastatic tumor tissue is confirmed by immunohistochemical evaluation regardless of intensity
8) KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed by KSCC central test.
9) Prior chemotherapy was done in the first study treatment before at least 2 weeks
10) Age 20 years<=
11) ECOG performance status 0-1
12) Life expectancy of 3 months
13) Patiens have enough organ function based on blood test within 1 week before registration.

1.WBC>=3,000/mm3 , 2.Neurtophils>=1,500/mm3
3. Platelets>=100,000/mm3
4. Hemoglobin>=9.0g/dl
5. Total bilirubin<=2.0mg/dl
6. AST<=upper limit of normal (ULN)*2.5
(<=ULN*5 in case of liver metastasis)
7.ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis)
8. Creatinine<=1.5mg/dl
9. creatinine clearance>=50ml/min

Key exclusion criteria

1) Severe bone marrow suppression
2) Severe infectious disease
3) Massive pleural effusion or ascites
4) Comorbidity or history of severe heart failure
5) Comorbidity or history of interstitial lung disease or pulmonary fibrosis
6) Paralytic or mechanical bowel obstruction
7) Jaundice
8)History of severe allergy
9)Impossible to evaluate disease by enhanced CT
10)Pregnant or lactating women or women of childbearing potential
11)Severe comorbidity (uncontrolable diabetes, hypertension, hypercarcemia etc)
12)Symptomatic brain metastasis
13)Simultaneous or metachronous double cancers
14)Patients who had received anti EGFR drug that include cetuximab.
15)Any other cases who are regarded as inadequate for study enrollment by the investigator.

Target sample size

39

Name of lead principal investigator

1st name
Middle name
Last name	Shoji Natsugoe

Organization

Kagoshima University Graduate School

Division name

Dept. Surgical Oncology

Zip code

Address

8-35-1 Sakuragaoka, Kagoshima 890-8520

TEL

099-275-5361

Email

kscc2@cres-kyushu.or.jp

Name of contact person

1st name
Middle name
Last name	KSCC

Organization

Clinical Research Support Center Kyushu

Division name

KSCC

Zip code

Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan

TEL

092-631-2920

Homepage URL

Email

kscc2@cres-kyushu.or.jp

Institute

Kyushu Study group of Clinical Cancer

Institute

Department

Personal name

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

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

九州大学（福岡県）国立病院機構九州医療ｾﾝﾀｰ（福岡県）九州中央病院（福岡県）済生会福岡総合病院（福岡県）済生会八幡総合病院（福岡県）新日鐵八幡記念病院（福岡県）国立病院機構福岡東医療ｾﾝﾀｰ（福岡県）田川病院（福岡県）仲原病院（福岡県）久留米大学（福岡県）久留米大学医療ｾﾝﾀｰ（福岡県）久留米第一病院（福岡県）聖マリア病院（福岡県）公立八女総合病院（福岡県）大牟田市立総合病院（福岡県）済生会唐津病院（佐賀県）健康保険諫早総合病院（長崎県）佐世保市立総合病院（長崎県）佐世保中央病院（長崎県）長崎大学（長崎県）光晴会病院（長崎県）柿添病院（長崎県）済生会熊本病院（熊本県）熊本大学（熊本県）健康保険人吉総合病院（熊本県）大分県立病院（大分県）大分赤十字病院（大分県）国立病院機構大分医療ｾﾝﾀｰ（大分県）国立病院機構別府医療ｾﾝﾀｰ（大分県）大分大学（大分県）中津市立中津市民病院（大分県）小林市立病院（宮崎県）宮崎県立延岡病院（宮崎県）宮崎江南病院（宮崎県）宮崎県立日南病院（宮崎県）国立病院機構南九州病院（鹿児島県）今給黎総合病院（鹿児島県）潤愛会鮫島病院（鹿児島県）鹿児島大学（鹿児島県）鹿児島厚生連病院（鹿児島県）鹿児島共済会南風病院（鹿児島県）慈愛会今村病院（鹿児島県）済生会川内病院（鹿児島県）出水郡医師会立阿久根市民病院（鹿児島県）県民健康ﾌﾟﾗｻﾞ鹿屋医療ｾﾝﾀｰ（鹿児島県）鹿児島県立薩南病院（鹿児島県）浦添総合病院（沖縄県）中頭病院（沖縄県）琉球大学（沖縄県）広島赤十字原爆病院（広島県）松山赤十字病院（愛媛県）有田共立病院（佐賀県）麻生飯塚病院（福岡県）宗像医師会病院（福岡県）熊本市立熊本市民病院（熊本県）国立病院機構都城病院（宮崎県）高野会高野病院（熊本県）天草地域医療ｾﾝﾀｰ（熊本県）福岡市民病院（福岡県）福岡新水巻病院（福岡県）防府消化器病ｾﾝﾀｰ防府胃腸病院（山口県）北九州総合病院（福岡県）岐阜大学病院（岐阜県）箕面市立病院（大阪府）川崎医科大学（岡山県）高地医療ｾﾝﾀｰ（高知県）関西医科大学（大阪府）徳島大学病院（徳島県）岡山大学病院（岡山県）名古屋大学医学部附属病院（愛知県）大阪府立急性期総合医療ｾﾝﾀｰ（大阪府）大阪医療ｾﾝﾀｰ（大阪府）岐阜市民病院（岐阜県）岐阜県総合医療ｾﾝﾀｰ（岐阜県）大阪府立成人病ｾﾝﾀｰ（大阪府）大阪医科大学附属病院（大阪府）健生会土庫病院（奈良県）

Date of disclosure of the study information

2009

Year

09

Month

11

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

2009

Year

06

Month

17

Day

Date of IRB

Anticipated trial start date

2009

Year

10

Month

01

Day

Last follow-up date

2013

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

09

Month

10

Day

Last modified on

2016

Year

09

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003034