UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006818 |
|---|---|
| Receipt number | R000008062 |
| Scientific Title | A multicenter, single-arm phase II trial of bevacizumab beyond initial progression in patients treated with first-line mFOLFOX6 followed by second-line FOLFIRI in Advanced Colorectal Cancer |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2016/11/16 08:52:16 |
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Basic information
Public title
A multicenter, single-arm phase II trial of bevacizumab beyond initial progression in patients treated with first-line mFOLFOX6 followed by second-line FOLFIRI in Advanced Colorectal Cancer
Acronym
CCOG-0801
Scientific Title
A multicenter, single-arm phase II trial of bevacizumab beyond initial progression in patients treated with first-line mFOLFOX6 followed by second-line FOLFIRI in Advanced Colorectal Cancer
Scientific Title:Acronym
CCOG-0801
Region
| Japan |
Condition
Condition
untreated and unresectable metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficacy and safety of bevacizumab beyond initial progression in patients treated with first-line mFOLFOX6 followed by second-line FOLFIRI in advanced colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2nd progression free survival (2nd PFS)
Key secondary outcomes
Progression free survival (PFS),overall survival (OS), response rate (ORR), disease control rate (DCR) and safty
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
bevacizumab plus mFOLFOX6 therapy (first-line treatment)
bevacizumab plus FOLFIRI therapy (second-line treatment)
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed colorectal adenocarcinoma.
2. Unresectable metastatic disease.
3. Age 20 to 74 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. No previous chemotherapy for mCRC.
6. Bidimensionally measurable disease.
7. A life expectancy of at least 3 months
8. Written informed consent was obtained.
9. Adequate organ function.
Key exclusion criteria
1. Previous history of severe drug-induced allergy
2. Brain metastasis
3. Cerebrovascular disease or its symptoms within 1 year.
4. Massive pleural effusion or ascites that required drainage.
5. History of active double cancer.
6. Previous history of thoromboembolitic disease, or necessity for antithrombotic drug.
7. Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer.
8. History of gastrointestinal perforation within 1 year.
9. Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy.
10. Severe renal failure or urinary protein (more than 2+).
11. Uncontrolled severe complications (DM, hypertension, diarrhea, et al.).
12. Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year.
13. Interstitial lung disease or pulmonary fibrosis.
14. Uncontrolled infection.
15. Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week.
16. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
17. Not appropriate for the study at the physician's assessment.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goro Nakayama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65 Tsurumai-chi, Showa-ku, Nagoya, Japan
TEL
0527442250
goro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goro Nakayama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65 Tsurumai-chi, Showa-ku, Nagoya, Japan
TEL
0527442250
Homepage URL
goro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Chubu Clinical Oncology Group (CCOG)
Institute
Department
Personal name
Funding Source
Organization
Chubu Clinical Oncology Group (CCOG)
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22886005
Number of participants that the trial has enrolled
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
Completed
Date of protocol fixation
| 2008 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 01 | Day |
Last modified on
| 2016 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008062
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