UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter phase II study of CapeOX (XELOX) with stop-and-go strategy as adjuvant chemotherapy in high-risk Stage II or Stage III colon and rectal cancer
Title of the study (Brief title)	COACH Trial (CCOG 1302)
Region	Japan

Condition
Condition	High-risk Stage II or stage III colon and rectum cancer(above the peritoneal reflection)
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of CapeOX and CapeOX with Oxaliplatin Stop-and-Go Strategy in curatively resected High-risk Stage II / Stage III colon cancer(above the peritoneal reflection) as adjuvant chemotherapies
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The frequency of peripheral sensory neuropathy 12 months after the treatment
Key secondary outcomes	"Disease-free survival rate Relaps-free survival rate Overall survival rate Oxaliplatin induced neuropathy rate Relative dose intensity Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	CapeOX(XELOX) (8 courses) Oxaliplatin 130mg/m2 day1 Capacitabine 2000mg/m2 day1 - 15(bid) every 3 weeks
Interventions/Control_2	(1)Initial therapy(2 courses) : CapeOX therapy (2)Maintenance therapy(4 courses) : Capecitabin therapy(omit the oxaliplatin) (3)Reintroduced therapy(2 courses) : CapeOX therapy
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Written informed consent (2) D2 or D3 lymph nodes resection and Curability A surgery (no residual tumor visible to macroscopically and/or microscopically). (3) Predominantly located in the cecum, colon, rectosigmoid region or rectum (above the peritoneal reflection) based on the findings from surgery and/or surgical specimen. (4) Pathological Stage III or High risk Stage II : High risk Stage II, defined as those with poor prognostic features, including 1) T4 tumors (UICC TNM 7th edition) 2) Bowel obstruction 3) Perforation 4) <12 lymph nodes examined 5) Poorly differentiated histology 6) Vascular or Lymphatic invasion (5) Registration and chemotherapy starting within 8 weeks after resection. (6) Age: 20-80 years (7) Performance status (PS) 0-1 (8) A life expectancy greater than 3 months (9) No prior chemotherapy, immunotherapy, or radiation therapy. (10) Adequate organ function
Key exclusion criteria	(1)Appendix cancer or anal cancer (2)Distal extent of tumor must be in the Rb (3)Multiple malignacies to be treated (4)Ileus, bowel obstruction or uncontrolled peptic ulcer. (5)Uncontrolled severe complications(DM, hypertension, diarrhea, et al.) (6)Massive pleural effusion or ascites that required drainage. (7) Patient with symptomatic cardiovascular disease or asymptomatic disease but has been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (8) A history of allergy to 5-FU, platina, or Known dihydropyrimidine dehydrogenase (DPD) deficiency. (9)Severe neuropathy (10)With interstitial lung disease or pulmonary fibrosis (11)Continuous systemic steroid therapy (oral or intravenous administration). (12)A history and/or current evidence of significant neurological and/or mental illness. (13)Pregnant (14)Without intention to contraception (15)Prior chemotherapy including Oxaliplatin or Capecitabin (16)Not appropriate for the study at the physician's assessment.
Target sample size	200

Research contact person
Name of lead principal investigator	Goro Nakayama
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL	(81)52-744-2253
Email	goro@med.nagoya-u.ac.jp

Public contact
Name of contact person	Miyuki Aoki
Organization	Chubu Clinical Oncology Group (CCOG)
Division name	Data Center
Address	65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL	(81)52-744-2253
Homepage URL	http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
Email	goro@med.nagoya-u.ac.jp

Sponsor
Institute	Chubu Clinical Oncology Group
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 09 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 12 Month 09 Day
Anticipated trial start date	2013 Year 12 Month 09 Day
Last follow-up date
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 12 Month 09 Day
Last modified on	2016 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013449