UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial comparing laparoscopic surgery with open surgery in palliative resection of primary tumor in incurable Stage IV colorectal cancer (JCOG1107)
Title of the study (Brief title)	Encore Trial: Trial of <en>doscopic palliative <co>lorectal <re>section for symptomatic unresectable colorectal cancer (JCOG1107)
Region	Japan

Condition
Condition	Unresectable Stage IV colorectal cancer and a synchronous symptomatic primary tumor
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the non-inferiority of laparoscopic primary tumor resection in overall survival compared to open resection for symptomatic unresectable colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Overall survival, proportion of conversion from laparoscopic surgery to open surgery, proportion of patients who fulfill the criteria of starting chemotherapy by 6 weeks after operation, intraoperative and postoperative complication, adverse events during chemotherapy, serious adverse events

Base
Study type	Interventional

Study design
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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	A: Open primary tumor 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 and oxaliplatin 130 mg/m2 as a 2-hour IV 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: Laparoscopic primary tumor resection followed by the same chemotherapy as arm A (mFOLFOX6 or CapeOX plus bevacizumab)
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	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 3. Primary tumor with bowel stenosis (no obstruction) and/or bleeding (Hb<9.0 or blood transfusion within 4 weeks). If emergency operation is needed, the patient is ineligible. 4. 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 enlargement 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 5. No apparent invasion to adjacent organs 6. No ascites above the pelvic cavity 7. Neither bone metastases nor brain metastases 8. No history of abdominal surgery 9. PS of 0, 1, or 2 10. Aged 20 to 74 years 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) AST=<100IU/L (4) ALT=<100IU/L
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) HBs antigen positive 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 6 months 13) Unstable angina pectoris, previous myocardial infarction, or arterial thrombotic event within 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 28 days
Target sample size	194

Research contact person
Name of lead principal investigator	Seigo Kitano
Organization	Oita University Faculty of Medicine
Division name	First Surgery
Address	1-1, Idaigaoka, Hazama-cho, Yufu-city, 879-5593 Japan
TEL	097-586-5843
Email	colonrct@oita-u.ac.jp

Public contact
Name of contact person	Tomonori Akagi, Masafumi Inomata
Organization	JCOG1107 Coordinating Office
Division name	First Surgery, Oita University Faculty of Medicine
Address	1-1, Idaigaoka, Hazama-cho, Yufu-city, 879-5593 Japan
TEL	097-586-5843
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

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） 栃木県立がんセンター（栃木県） 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） 埼玉医科大学国際医療センター（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） 順天堂大学医学部附属浦安病院（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） 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） 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） 大阪国際がんセンター（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） 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） 岡山済生会総合病院（岡山県） 広島市立広島市民病院（広島県） 県立広島病院（広島県） 広島市立安佐市民病院（広島県） 福山市民病院（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）

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 11 Month 09 Day
Anticipated trial start date	2013 Year 01 Month 07 Day
Last follow-up date	2024 Year 07 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 07 Day
Last modified on	2018 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011318