UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the reintroducing FOLFOX or XELOX +/- BV in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy.(REACT study)
Title of the study (Brief title)	Evaluation of the reintroducing FOLFOX or XELOX +/- BV in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy.(REACT study)
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the feasibility and effectiveness of FOLFOX or XELOX +/- BV therapy for recurrent colorectal cancer after more than 6 months post adjuvant chemotherapy including L-OHP(FOLFOX, XELOX, or SOX).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	response rate disease control rate
Key secondary outcomes	safety progression free survival time to treatment failure overall survival relative dose intensity

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	FOLFOX +/- BV therapy L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 +/- BV:5mg/m2 XELOX +/- BV therapy L-OHP:130mg/m2 Cape:2,000mg/day +/- BV:7.5mg/m2
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Colorectal cancer proven by histology. 2)Past history of adjuvant chemotherapy including L-OHP (FOLFOX, XELOX or SOX) with a cumulative dose of more than 400 mg/m2. 3)Reccernce observed by imaging after more than 6 months post adjuvant chemotherapy. 4)Presence of at least one measurable lesion using the RECIST (ver1.1 guidelines). 5)ECOG Performance status(PS) of 0-2. 6)Age of 20 years or older. 7)Laboratory data within 14 days. neutrophil >=1,500/mm3 platelet >=100,000/mm3 hemoglobin >=8.0g/dL Cr <=2.0 UNL T-Bil <=2.0 ULN AST and ALT <=2.5 ULN (<=5.0 ULN in case of liver metastasis) 8)Written informed consent.
Key exclusion criteria	1)Blood transfusion, administration of hematopoietic factor (human blood products or G-CSF, etc). 2)Serious drug allergy. 3)Peripheral sensory neuropathy >= Grade 2. 4)Active synchronous malignancies. 5)Massive pleural or pericardial effusion ,or ascites. 6)Infection of clinical issue or fever suspicious of infection. 7)Brain metastasis. 8)Cardiac disease complications (congested heart failure, symptomatic coronary artery disease, uncontrollable cardiac dysrhythmia or history of myocardial infarction within 12 months, etc). 9)Lung disease of clinical issue. 10)Bleeding that requires medication or transfusion. 11)Uncontrolled diarrhea. 12)Ileus or bowel obstruction. 13)Clinically significant mental or psychological disease. 14)Insulin-treated diabetic patients. 15)Women who are pregnant or breast-feeding. 16)Other patients who are unfit for the study as determined by the attending physician.
Target sample size	30

Research contact person
Name of lead principal investigator	Masahito Kotaka
Organization	Sano Hospital
Division name	Gastrointestinal Cancer Center
Address	Shimizugaoka 2-5-1, Tarumi-ku, Kobe
TEL	078-785-1000
Email	tomomakotaka6410@yahoo.co.jp

Public contact
Name of contact person	Masahito Kotaka
Organization	Sano Hospital
Division name	Gastrointestinal Cancer Center
Address	Shimizugaoka 2-5-1, Tarumi-ku, Kobe
TEL	078-785-1000
Homepage URL
Email	tomomakotaka6410@yahoo.co.jp

Sponsor
Institute	Hyogo College of Medicine, Department of Surgery
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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 10 Month 11 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 09 Month 05 Day
Anticipated trial start date	2011 Year 11 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 10 Month 11 Day
Last modified on	2017 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007733