UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseII trial of neoadjuvant chemotherapy for recurrent colorectal cancer with resectable extra hepatic metastases
Title of the study (Brief title)	N-SOG 07
Region	Japan

Condition
Condition	recurrent colorectal cancer with resectable extra hepatic metastases
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of neoadjuvant chemotherapy for recurrent colorectal cancer with resectable extra hepatic metastases
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	treatment completion rate
Key secondary outcomes	R0 resection rate, pCR rate, adverse event, response rate, recurrence free survival, 3-year disease free survival, overall survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Neoadjuvant chemotherapy with FOLFOX plus panitumumab followed by surgery
Interventions/Control_2	Neoadjuvant chemotherapy with FOLFIRI plus panitumumab followed by surgery
Interventions/Control_3	Neoadjuvant chemotherapy with FOLFOX plus bevacizumab followed by surgery
Interventions/Control_4	Neoadjuvant chemotherapy with FOLFIRI plus bevacizumab followed by surgery
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) Histologically confirmed adenocarcinoma of colorectal cancer 2) Chemotherapy un-treating and having existing treated do not ask. 3) Analysis result of KRAS gene becomes clear by 2 course start 4) Recurrent colorectal cancer with resectable extra hepatic metastases 5) Already resected, or resectable 6)Without prior surgery,chemotherapy, radiotherapy and radiofrequency ablation for the target metastases 7)Performance status(PS) 0-1 8)Age:20-80 years 9)Alife expectancy greater than 12 weeks 10)Adequate organ function within 14 days before chemotherapy 11) Written informed consent
Key exclusion criteria	1)History of drug hypersensitivity 2)Dysesthesia 3) Contraindications to using drugs 4)Multiple malignacies to be treated 5)Have hematopoietic drugs within 7days before enrollment 6)Uncontrolled body cavity fluid 7)Serious infection 8)With brain metastases 9)Significant abnormal ECG or history of cardiovascular disease 10)Serious lung disease 11)With hemorrhage 12)Uncontrolled diarrhea 13)With Intestinal paralysis, or obstruction 14)History of central nervous system disorder 15) With dementia,or severe mental disorder 16) Gravida or lactating woman 17)Not suitable for participation with any other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	Masato Nagino
Organization	Nagoya University Graduated School of Medicine
Division name	Division of Surgical Oncology
Address	65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL	052-744-2222
Email

Public contact
Name of contact person	Keisuke Uehara
Organization	Nagoya University Graduated School of Medicine
Division name	Division of Surgical Oncology
Address	65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL	052-744-2222
Homepage URL
Email	kuehara@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya Surgical 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	2011 Year 11 Month 28 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 09 Month 14 Day
Anticipated trial start date	2011 Year 10 Month 01 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	2011 Year 11 Month 28 Day
Last modified on	2018 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008028