UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II multicenter study of neoadjuvant chemotherapy with XELOX for locally advanced rectal cancer
Title of the study (Brief title)	KYNAC 02
Region	Japan

Condition
Condition	Stage II or III rectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of neoadjuvant chemotherapy with XELOX for locally advanced rectal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	R0 resection rate
Key secondary outcomes	completion rate of the scheduled chemotherapy,Pathologic response rate,pathological complete response rate,downstage rate, OS, DFS, Local recurrence rate, Rate of sphincter-preservation, Completion rate of postoperative adjuvant chemotherapy, acute toxicity, postoperative complications,postoperative defecation

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Capecitabine: at a dose of 1000mg/m2 twice daily on days 1-14, 22-35,43-56,63-76 Oxaliplatin: at a dose of 130mg/m2 on days 1, 22,43,63 Surgical resection: 2-8 weeks after the completion of chemotherapy
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Histologically confirmed adenocarcinoma of the rectum 2.Patients with cT4 or cN2/3 3. Tumor with inferior edge located below peritoneal reflection 4. Without history of chemotherapy or radiotherapy for rectal cancer 5. Eastern Cooperative Oncology Group performance status of 0 or 1 6. Adequate organ function i) WBC >=3,000/mm3 ii) Neutrophil count >=1,500/mm3 iii) Platelet count >=100,000/mm3 iv) Serum bilirubin <=2.0mg/dl v) AST <=100IU/l vi) ALT <=100IU/l vii) Serum creatinine <=1.5mg/dl 7. Written study-specific informed consent
Key exclusion criteria	1. With distant metastasis (M1) 2. Cancerous fluid 3. Active infectious disease 4. Concomitant malignancy (within 5 years) and double cancer 5. Uncontrolled diabetic 6. Peripheral neuropathy 7. Serious lung disease 8. Clinically significant cardiac disease 9. Pregnant women and nursing mothers, possibly pregnant women, and men attempting to conceive a child 10. Other conditions judged ineligible by physician
Target sample size	35

Research contact person
Name of lead principal investigator	Masafumi Nakamura,MD
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Surgery and Oncology
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
TEL	092-642-5437
Email	mnaka@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person	Tatsuya Manabe,MD
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Surgery and Oncology
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5440
Homepage URL
Email	manabe@surg1.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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

Other related organizations
Co-sponsor	Surgical Oncology Group of Kyushu and Yamaguchi (SOGKY)
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	2016 Year 10 Month 11 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 01 Month 25 Day
Anticipated trial start date	2016 Year 10 Month 31 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	2016 Year 10 Month 11 Day
Last modified on	2016 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028039