UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study of capecitabine and oxaliplatin (XELOX) for patients with stage II/III colon cancer.
Title of the study (Brief title)	ACTOR study
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate feasibility, safety and efficacy of adjuvant XELOX in patients with stage II/III colon cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Completion rate of treatment
Key secondary outcomes	1 Completion rate of L-OHP 2 Disease-free survival 3 Recurrent-free survival 4 Overall survival 5 Adverse effect 6 Correlation of relative dose intensity with prognosis 7 Correlation of stage with prognosis

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	XELOX Capecitabine:2000mg/m2 d1-14 Oxaliplatin:130mg/m2 d1 Q3w
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. Histological confirmation of stage II/III colorectal cancer. 2. Prior surgical resection with D2 or greater lymphadenectomy. 3. Surgical diagnosis as Cur A. 4. Adjuvant chemotherapy is planned within 8 weeks after surgery. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 6. No history of prior chemotherapy or radiation. 7. Age of 20 years or older. 8. Capable of oral intake. 9. Vital organ functions (listed below) are preserved within 2 weeks prior to entry i. WBC4000/mm3 or greater (12,000/mm3 or lesser) ii. Neurtophils: 2000/mm3 or greater iii. Platelets: 100,000/mm3 or greater iv. Hemoglobin: 9.0g/dl or greater v. AST and ALT: upper limit of normal (ULN)*2.5 or lesser. vi. Total bilirubin: upper limit of normal (ULN)*2 or lesser. vi. Serum creatinine: upper limit of normal (ULN)*1.25 or lesser. 10. Written informed consent
Key exclusion criteria	1. Severe peripheral sensory neuropathy 2. History of the serious hypersensitivity for drugs. 3. Active infection. 4. Complications (Evidence of interstinal lung disease, or pulmonary fibrosis, paralytic or mechanical bowel obstruction, uncontrolled hypertension, uncontrolled diabetes mellitus, cirrhosis, active cardiovascular disease, or past or current history (within 3 months) of myocardial infarction. 5. Multiple primary cancer within 5years. 6. Uncontrolled diarrhea. 7. Clinically significant mental or psychological disease. 8. Pregnancy, lactation period. 9. Other conditions not suitable for this study
Target sample size	36

Research contact person
Name of lead principal investigator	Nobuyuki Mizunuma
Organization	The Cancer Institute Hospital of JFCR
Division name	Gastroenterology
Address	135-8550, 3-8-31 Ariake Koto-ku Tokyo
TEL	+81-3-3520-0111
Email	mizunuma@jfcr.or.jp

Public contact
Name of contact person	Mitsukuni Suenaga
Organization	The Cancer Institute Hospital of JFCR
Division name	Gastroenterology
Address	135-8550, 3-8-31 Ariake Koto-ku Tokyo
TEL	+81-3-3520-0111
Homepage URL
Email	m.suenaga@jfcr.or.jp

Sponsor
Institute	Japanese Foundation for Cancer Research
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	公益財団法人がん研究会有明病院

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 16 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2017 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2012 Year 05 Month 26 Day
Last modified on	2018 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009455