UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011680 |
|---|---|
| Receipt number | R000013519 |
| Scientific Title | Multicenter Phese II Study of SOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral S-1 plus Bevacizumab Maintenance Therapy in Advanced Colorectal CancerC |
| Date of disclosure of the study information | 2013/09/08 |
| Last modified on | 2016/11/16 09:07:21 |
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Basic information
Public title
Multicenter Phese II Study of SOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral S-1 plus Bevacizumab Maintenance Therapy in Advanced Colorectal CancerC
Acronym
CCOG1002.1
Scientific Title
Multicenter Phese II Study of SOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral S-1 plus Bevacizumab Maintenance Therapy in Advanced Colorectal CancerC
Scientific Title:Acronym
CCOG1002.1
Region
| Japan |
Condition
Condition
Unresectable metastatic or recurrent colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of SOX (S-1+L-OHP) plus bevacizumab therapy considering Oxaliplatin Stop-and-Go Strategy 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
DDC ; Duration of disease control)
Key secondary outcomes
TTF;Time to treatment-failure, PFS;Progression free-survival, OS;Overall survival, RR;Response rate, Reintroduction rate of SOX+bavacizumab therapy, 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
(1)Initial therapy
: SOX+bevacizumab therapy
Bev : 7.5 mg/kg (90 min)
L-OHP : 130 mg/m2 (120 min)
S-1 : 80 - 120 mg/day (Day1-15)
(2)Maintenance therapy
: S-1+bevacizumab therapy
Bev : 7.5 mg/kg (90 min)
S-1 : 80 - 120 mg/day (Day1-15)
(3)Reintroduced therapy
: SOX+bevacizumab therapy
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) Histopathologically confirmed colorectal cancer.
(2) Written informed consent.
(3) Age of 20 years or older.
(4) ECOG performance status 0-1.
(5) Life expectancy greater than 3 months.
(6) Measurable or evaluable disease (RECIST ver.1.1.).
(7) Untreated colorectal cancer.
(8) Unresectable advanced colorectal cancer patient who have received no treatment without operation.
(9) Reccurent colorectal cancer patient who have received no treatment for reccurence.
(10) Adequate organ function.
Key exclusion criteria
1) Previous history of severe drug-induced allergy.
2) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers, and man who wish to become his partner pregnancy.
3) Uncontrolled infection.
4) Uncontrolled severe complications (Interstitial lung disease, pulmonary fibrosis, renal failure, liver failure, DM, hypertension, et al.).
5) Patient with symptomatic cardiovascular disease or asymptomatic disease.
6) Patient who have peripheral nerve disorder.
7) Patient who have severe diarrhea.
8) Massive pleural effusion or ascites that required drainage.
9) Brain metastasis
10) History of Interstitial lung disease.
11) History of active double cancer.
12) Systemic administration of steroid.
13) Contraindication of S-1, L-OHP, Bevacizumab.
14) Not appropriate for the study at the physician's assessment.
15) Patient receiving surgical procedure within 28days.
16) History of gastrointestinal perforation within 6 months.
17) Patient who have gastrointestinal ulcer or bleeding.
18) Diathesis of bleeding or coagulopathy.
19) History of thoromboembolitic disease.
20) Patient with untreated traumatic bone fracture.
21) Systemic administration of antiplatelet drug, aspirin, and NSAIDS.
22) History of hemoptysis.
23) Colorectal cancer with obstruction.
24) Peritoneum dissemination confirmed by imaging
Target sample size
40
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 Gastroenterology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya-city Aichi Japan
TEL
(81)52-744-2253
goro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyuki Aoki |
Organization
Chubu Clinical Oncology Group(CCOG)
Division name
Data center
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL
(81)52-744-2253
Homepage URL
http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
goro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Chubu Clinical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 09 | Month | 08 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 08 | 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=R000013519
