UMIN-CTR Clinical Trial

Public title

A randomized controlled trial comparing resection of primary tumor plus chemotherapy with chemotherapy alone in incurable Stage IV colorectal cancer(JCOG1007, iPACS)

Acronym

A randomized controlled trial comparing resection of primary tumor plus chemotherapy with chemotherapy alone in incurable Stage IV colorectal cancer(JCOG1007, iPACS)

Scientific Title

A randomized controlled trial comparing resection of primary tumor plus chemotherapy with chemotherapy alone in incurable Stage IV colorectal cancer(JCOG1007, iPACS)

Scientific Title:Acronym

A randomized controlled trial comparing resection of primary tumor plus chemotherapy with chemotherapy alone in incurable Stage IV colorectal cancer(JCOG1007, iPACS)

Region

Japan

Condition

Unresectable Stage IV colorectal cancer and a synchronous asymptomatic primary tumor

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the survival benefit and safety of primary resection plus chemotherapy compared to chemotherapy alone in asymptomatic stage IV colorectal cancer with synchronous unresectable metastatic disease

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Overall survival

Key secondary outcomes

Progression-free survival, Adverse events, proportion of R0 resection after response to chemotherapy, proportion of palliative resection in chemotherapy alone arm

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

A: Chemotherapy alone (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks)

Interventions/Control_2

B: Primary resection followed by chemotherapy (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks)

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

74

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Pathologically proven adenocarcinoma or adenosquamous carcinoma
2. Primary tumor located at Cecum, Ascending, Transverse, Descending, Sigmoid, Rectosigmoid, or Upper rectum
3. No bowel obstruction.
4. No active bleeding, bowel perforation, or fistula formation
5. Having at least one to up to three unresectable factors among the following four factors:
1) Hepatic metastases with the predicted remnant functional parenchyma of less than 30%
2) Pulmonary metastases meeting one of the followings:
i) Invasion suspected to the mediastinum, heart, large vessels, trachea, esophagus, vertebral body, or tracheal bifurcation
ii) Predicted postoperative lung function (%FEV1.0) of less than 40%
iii) Requiring total pneumonectomy for removal of all metastatic tumors
iv) Malignant pleural effusion or pleural dissemination
3) Distant lymph node (LN) metastases with 10 mm or greater short axis which fulfill one of the followings by CT scan:
i) LN enlargement located above the lower edge of renal vein
ii) LN along the common hepatic artery or the hepatoduodenal ligament with hepatic metastases
iii) Mediastinal or hilar LN enlargement with pulmonary metastases
4) Peritoneal metastases meeting one of the followings:
i) Multiple irregularities or strictures of the intestinal walls confirmed by imaging
ii) Peritoneal tumor above the transverse colon
6. No apparent invasion to adjacent organs
7. No ascites above the pelvic cavity
8. Neither bone metastases nor brain metastases
9. PS of 0 or 1
10. Aged 20 to 74years old
11. No prior treatment of chemotherapy or radiation therapy against any other malignancies, including colorectal cancer
12. Adequate organ functions defined as below
1) Neutrophil count >=1,500/mm3
2) Platelet count >=100000/mm3
3) Hemoglobin >=9.0g/dL without any transfusion 4weeks before enrollment
4) AST=<100IU/L
5) ALT=<100IU/L
6) T.Bil=<2.0mg/dL
7) Cr=<1.5mg/dL
8) PT-INR=<1.5
13. Diarrhea and peripheral neuropathy of grade 1 or less
14. Written informed consent

Key exclusion criteria

1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma
2) Infectious disease to be treated
3) Positive for HBs antigen
4) Body temparature >= 38c
5) Women during pregnancy, possible pregnancy or breast-feeding
6) Severe mental disease
7) Currently treated with systemic steroids
8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema
9) Uncontrollable diabetes mellitus or routine administration of insulin
10) Uncontrolled hypertension, defined as systolic >= 150 and/or diastolic >= 100 mmHg
11) New York Heart Association class III /IV cardiac disease or congestive heart failure that would take medication in order to prevent lethal ventricular arrhythmias
12) Gastrointestinal fistula, perforation, or abscess within the past 6 months
13) Unstable angina pectoris, previous myocardial infarction, or arterial thrombotic event within the past 6 months
14) Abdominal aortic aneurysm (>= 5cm), thoracic aortic aneurysm (>= 6cm), or aortic dissection
15) Congenital hemorrhagic diathesis, coagulation disorder, or significant episodes of acute bleeding of grade 3 or more according to CTCAE ver.4.0 within the past 28 days
16) Episodes of hemoptysis within the past 28 days

Target sample size

770

Name of lead principal investigator

1st name
Middle name
Last name	Yukihide Kanemitsu

Organization

National Cancer Center Hospital

Division name

Department of Gastrointestinal Surgery

Zip code

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045

TEL

03-3542-2511

Email

ykanemit@ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Yukihide Kanemitsu

Organization

JCOG1007Coordinating Office

Division name

National Cancer Center Hospital

Zip code

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045

TEL

03-3542-2511

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

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

札幌厚生病院（北海道）
岩手医科大学（岩手県）
宮城県立がんセンター（宮城県）
山形県立中央病院（山形県）
群馬県立がんセンター（群馬県）
防衛医科大学校（埼玉県）
埼玉県立がんセンター（埼玉県）
自治医科大学附属さいたま医療センター（埼玉県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
国立がん研究センター中央病院（東京都）
杏林大学医学部（東京都）
東京医科大学病院（東京都）
がん・感染症センター都立駒込病院（東京都）
慶應義塾大学病院（東京都）
東京医科歯科大学（東京都）
東邦大学医療センター大橋病院（東京都）
神奈川県立病院機構神奈川県立がんセンター（神奈川県）
北里大学医学部（神奈川県）
昭和大学横浜市北部病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
済生会横浜市南部病院（神奈川県）
平塚市民病院（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
新潟県厚生連長岡中央綜合病院（新潟県）
富山県立中央病院（富山県）
石川県立中央病院（石川県）
長野市民病院（長野県）
岐阜大学医学部（岐阜県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
藤田保健衛生大学（愛知県）
国立病院機構京都医療センター（京都府）
大阪大学医学部（大阪府）
大阪府立病院機構大阪府立成人病センター（大阪府）
国立病院機構大阪医療センター（大阪府）
大阪府立病院機構大阪府立急性期・総合医療センター（大阪府）
大阪市立総合医療センター（大阪府）
大阪医科大学（大阪府）
堺市立総合医療センター（大阪府）
箕面市立病院（大阪府）
市立吹田市民病院（大阪府）
関西労災病院（兵庫県）
兵庫医科大学（兵庫県）
医療法人薫風会佐野病院（兵庫県）
島根大学医学部（島根県）
広島市立広島市民病院（広島県）
県立広島病院（広島県）
福山市民病院（広島県）
広島市立安佐市民病院（広島県）
国立病院機構四国がんセンター（愛媛県）
高知医療センター（高知県）
久留米大学医学部（福岡県）
熊本大学医学部（熊本県）
大分大学医学部附属病院（大分県）

Date of disclosure of the study information

2012

Year

06

Month

12

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

Completed

Date of protocol fixation

2012

Year

04

Month

25

Day

Date of IRB

2012

Year

05

Month

24

Day

Anticipated trial start date

2012

Year

06

Month

12

Day

Last follow-up date

2020

Year

12

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2020

Year

06

Month

10

Day

Other related information

Registered date

2012

Year

06

Month

12

Day

Last modified on

2021

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009389