UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007190 |
|---|---|
| Receipt number | 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 08:24:39 |
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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
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
hmishima@aichi-med-u.ac.jp
Public contact
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
chigusa.abe@ecrin.or.jp
Sponsor or person
Institute
Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008367
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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