UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bi-weekly capecitabine and oxaliplatin plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer
Title of the study (Brief title)	PHOENiX trial
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 evaluate the efficacy and safety of bi-weekly XELOX plus bevacizumab as first line treatment in patients with metastatic colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Response rate Overall survival Time to treatment failure Relative dose intensity Safety

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	Bi-weekly XELOX+bevacizumab
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. Histologically confirmed colorectal cancer. 2. No prior chemotherapy for metastatic disease. 3. Measurable lesion based on RECIST ver1.1. 4. Written informed consent 5. Age of at least 20 years. 6. ECOG PS of 0 or 1 7. A life expectancy of more than 3 months. 8. Adequate function of vital organs, including normal hematopoietic, liver and renal function: White blood cell count >= 3,000/mm3 and <= 12,000/mm3. Platelets>=100,000/mm3. Hemoglobin> =9.0g/dl Total bilirbin> =2.0mg/dl Aspartate aminotransferase and alanine aminotransferase levels <=100IU/I (200IU/I in case of liver metastasis) Serum creatinine level male:less than 1.8mg/dl female: less than 1.35mg/dl Urinary protein less than 1+
Key exclusion criteria	1. Serious renal dysfunction 2. Serious drug hypersensitivity or a history of drug allergy 3. Active multiple primary neoplasm 4. Active infections 5. Serious heart disease 6. History of thrombosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 7. Fresh gastrointestinal hemorrhage, intestinal obstruction or peptic ulcer 8. Pleural effusion, peritoneal fluid and pericardial fluid 9. Symptomatic brain metastasis 10. History of mental disturbances or cerebrovascular disorder 11. Uncontrolled high blood pressure and diabetes 12. Uncontrolled diarrhea 13. Serious non-healing wound and/or major surgical procedure within 4 weeks prior to enrollment 14. Traumatic fracture not healed 15. Bleeding tendency and anti-platelets therapy (including aspirin and NSAIDS) 16. Pregnant or possibly pregnant, and nursing women 17. Peripheral neuropathy 18. Other conditions not suitable for this study
Target sample size	45

Research contact person
Name of lead principal investigator	Hideyuki Mishima
Organization	Aichi Medical University
Division name	Cancer Center
Address	1-1, Yazakokarimata, Nagakute, Aichi
TEL	0561-62-3311
Email	hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person	Chigusa Abe
Organization	Epidemiological and Clinical research Information Network (ECRIN)
Division name	Data Center
Address	21-7 Shogoinn Sakyo-ku, Kyoto
TEL	075-762-1227
Homepage URL
Email	chigusa.abe@ecrin.or.jp

Sponsor
Institute	Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department

Funding Source
Organization	Epidemiological and Clinical research Information Network (ECRIN)
Organization
Division
Category of Funding Organization	Non profit foundation
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	2012 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 25 Day
Anticipated trial start date	2012 Year 01 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	Published
URL releasing results
Results	RESULTS: A total of 51 patients were enrolled from 14 institutions from December 2011 to July 2012. The median age was 66 (range=38-85) years, 29 (56.9%) had colonic cancer and 22 (43.1%) had rectal cancer in this study. Pertinent grade 3/4 toxicities were neutropenia (13.7%), peripheral neuropathy (13.7%), hypertension (13.7%), gastrointestinal perforation (3.9%), and hand-foot syndrome (5.9%). The response rate was 51% (one complete and 25 partial responses). Median PFS and TTP were 344 days and 196 days, respectively. Median overall survival has not been reached yet.
Other related information	Bi-weekly Capecitabine-Oxaliplatin (XELOX) plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer -The PHOENiX Trial. Matsui T, Nagata N, Hirata K, Okazaki S, Sato S, Nakamura M, Kim H, Oba K, Sakamoto J, Mishima H. Anticancer Res. 2016 Jul;36(7):3437-43.

Management information
Registered date	2012 Year 02 Month 01 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008367