UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II Study of Capecitabine, Oxaliplatin (XELOX) and Bevacizumab for patient with high-risk Upper Rectal Cancer as Neo-Adjuvant chemotherapy.
Acronym	COBURA study
Scientific Title	A Phase II Study of Capecitabine, Oxaliplatin (XELOX) and Bevacizumab for patient with high-risk Upper Rectal Cancer as Neo-Adjuvant chemotherapy.
Scientific Title:Acronym	COBURA study
Region	Japan

Condition
Condition	Upper rectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of neoadjuvant XELOX plus Bevacizumab for high-risk advanced upper rectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	R0 resection rate
Key secondary outcomes	Safety (incidence of adverse events), Pathological complete response (pCR), Down-staging rate, Disease-free survival (DFS), local recurrence rate.

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+BEV (4 courses) as neoadjuvant setting. Capecitabine: 2000mg/m2 d1-14 Oxaliplatin: 130mg/m2 d1 Bevacizumab: 7.5mg/kg d1 Q3w (if needed, CRT is applied after completion of neoadjuvant 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Written informed consent 2. Age: 20- years old. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 4. Life expectancy greater than or equal to 3 months 5. Histological confirmation of adenocarcinoma. 6. Site of primary tumor, Rectal (Rs~Ra) cancer. i. TNM ver.7. N2 ii. Japanese classification ver.8., metastasis to lymph node No.252 or No.253. iii. circumferential resection margin <or= 1mm iv. T4 vi. Maximum dimension of tumor >or=80mm vii. Mesorectal fat invasion >or=5mm 7. Vital organ functions (listed below) are preserved within 2 weeks prior to entry. i. Neutrophils>or=1500/mm3 ii. Platelets>or=100,000/mm3 iii. Hemoglobin>or=9.0g/dl iv. AST, ALT and ALP =or<upper limit of normal (ULN)*2.5 v. Total bilirubin =or<upper limit of normal (ULN)*1.5 vi. Serum creatinine =or<upper limit of normal (ULN)*1.5
Key exclusion criteria	1. Malignant coelomic fluid. 2. Multiple primary cancer within 5 years. 3. History of intrapelvic irradiation. 4. Clinically significant complication (heart failure, interstitial lung disease or pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure, etc.) 5. History of the serious hypersensitivity for any agents. 6. Uncontrolled diarrhea. 7. Evidence of peripheral sensory neuropathy. 8. Uncontrolled Active infection. 9. Other conditions not suitable for this study.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Akiyoshi
Organization	Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name	Gastroenterological Surgery
Zip code	135-8550
Address	3-8-31, Ariake, Koto-ku, Tokyo
TEL	+81-3-3520-0111
Email	takashi.akiyoshi@jfcr.or.jp

Public contact
Name of contact person	1st name Mitsukuni Middle name Last name Suenaga
Organization	Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name	Gastroenterology
Zip code	135-8550
Address	3-8-31, Ariake, Koto-ku, Tokyo
TEL	+81-3-3520-0111
Homepage URL
Email	m.suenaga@jfcr.or.jp

Sponsor
Institute	Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization	Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of the Cancer Institute Hospital of JFCR
Address	3-8-31, Ariake, Koto-ku, Tokyo, Japan
Tel	+81-3-3520-0111
Email	med.shinsa@jfcr.or.jp

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	2014 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	19
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 02 Month 06 Day
Date of IRB	2014 Year 07 Month 23 Day
Anticipated trial start date	2014 Year 11 Month 06 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 11 Month 27 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018296