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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007190
Receipt No. R000008367
Scientific Title Bi-weekly capecitabine and oxaliplatin plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer
Date of disclosure of the study information 2012/02/01
Last modified on 2018/09/20

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Basic information
Public title Bi-weekly capecitabine and oxaliplatin plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer
Acronym PHOENiX trial
Scientific Title Bi-weekly capecitabine and oxaliplatin plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Hideyuki Mishima
Organization Aichi Medical University
Division name Cancer Center
Zip code
Address 1-1, Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Email hmishima@aichi-med-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Chigusa Abe
Organization Epidemiological and Clinical research Information Network (ECRIN)
Division name Data Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.

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 Completed
Date of protocol fixation
2011 Year 11 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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