UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001233 |
|---|---|
| Receipt number | R000001503 |
| Scientific Title | Phase II clinical trial of the first-line Stop-and-Go modified FOLFOX6 and bevacizmab for patients with unresectable/recurrent colorectal cancer |
| Date of disclosure of the study information | 2008/07/07 |
| Last modified on | 2012/01/12 12:37:18 |
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Basic information
Public title
Phase II clinical trial of the first-line Stop-and-Go modified FOLFOX6 and bevacizmab for patients with unresectable/recurrent colorectal cancer
Acronym
Phase II clinical trial of the first-line Stop-and-Go modified FOLFOX6 and bevacizmab for patients with unresectable/recurrent colorectal cancer
Scientific Title
Phase II clinical trial of the first-line Stop-and-Go modified FOLFOX6 and bevacizmab for patients with unresectable/recurrent colorectal cancer
Scientific Title:Acronym
Phase II clinical trial of the first-line Stop-and-Go modified FOLFOX6 and bevacizmab for patients with unresectable/recurrent colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of first-line Stop-and-Go modified FOLFOX6 and bevacizumab for patients with unresectable/recurrent colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
The incidence of adverse events
Time to treatment failure
Progression-free survival
Overall survival
The incidence of grade 3 neurotoxicity
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
After 8 cycles of modified FOLFOX 6 with bevacizmab, patients receive sLV5FU2 with bevacizumab (until 8 cycles are completed or disease progression). And then, patients receive modified FOLFOX6 with bevacizmab (until 8 cycles are completed or disease progression.)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) unresectable or recurrent colorectal cancer.
2) Histologically documented adenocarcinoma, mucinous carcinoma, or signet ring cell carcinoma of the colon or rectum. In the recurrent case, histology of the primary site must have been histologically confirmed in the past. Additiona histological confirmation of metastatic lesion or recurrent site is not necessary.
3) Age more than 20years and less than 75 years.
4) ECOG performance status of 0,1 or 2.
5) At least one measurable lesion based on the RECIST criterion.
6) No prior therapies for metastatic and/or recurrent disease. Prior adjuvant therapy is allowed if it is completed at least 24 weeks before registration. No neo-adjuvant chemotherapy is allowed.
7) Required baseline laboratory parameters (within 7 days before registration):
Hb more than 8.0g/dl
WBC more than 3000 and WBC less than 12000/ul
Plt more than 100,000/ul
T-Bil less than 1.5mg/dl
GOT less than 100 IU/l
GPT less than 100 IU/l
Cre less than 1.5mg/dl
8) Signed informed consent of the patient for the registration.
Key exclusion criteria
1) active other malignancies
2) history of the severe drug hypersensitivity
3) clinically significant infectious disease(body temperature less than 38.0 degrees)
4) severe complications (ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, hepatic failure and so on)
5) uncontrollable hypertension
6) urinary protein (more than 1+)
7) Patients who have abnormal findings on ECG and need any treatment (within 2 weeks before the registration.)
8) Moderate/severe pleural effusion or ascites
9) Symptomatic brain metastasis
10) Any significant bleedings
11) Evidence of bleeding diathesis
12) History of thoromboembolitic disease
13) Uncontrolled watery diarrhea.
Watery colostomy output without trouble with patient's daily living is allowed.
14) Surgical procedure within 4 weeks before registration (the implanted central venous port is allowed.)
15) Patient who underwents the implantation of the central venous port within a day prior to start of study drugs.
16) Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who don't intend to have protected intercourse.
17) Any other cases who are regarded as
Inadequate for study enrollment by the attending doctors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken KATO |
Organization
National Cancer Center Hospital
Division name
Department of Internal Medicine
Zip code
Address
5-1-1 Tsukiji Chuou-ku Tokyo
TEL
03-3542-3815
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuko OKITA |
Organization
National Cancer Center Hospital
Division name
Department of Internal Medicine
Zip code
Address
5-1-1 Tsukiji Chuou-ku Tokyo
TEL
03-3542-3815
Homepage URL
natukot@gmail.com
Sponsor or person
Institute
Mlnlstry of health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
None
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
National Cancer Center Hospital
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.springerlink.com/content/2gt77q9v3130737q/
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
| 2007 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 07 | Month | 07 | Day |
Last modified on
| 2012 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001503
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
