UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017102 |
|---|---|
| Receipt number | R000019805 |
| Scientific Title | Phase II trial of FOLFOXIRI + Bevacizumab in patients with untreated metastatic colorectal cancer |
| Date of disclosure of the study information | 2015/04/19 |
| Last modified on | 2020/03/20 11:11:09 |
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Basic information
Public title
Phase II trial of FOLFOXIRI + Bevacizumab in patients with untreated metastatic colorectal cancer
Acronym
Bevacizumab + Triplet treatment for untreated metastatic colorectal cancer
Scientific Title
Phase II trial of FOLFOXIRI + Bevacizumab in patients with untreated metastatic colorectal cancer
Scientific Title:Acronym
Bevacizumab + Triplet treatment for untreated metastatic colorectal cancer
Region
| Japan |
Condition
Condition
Patients with metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of FOLFOXIRI + bevacizumab in untreated metastatic colorectal cancer patients who harbor UGT1A1*1/*1, *1/*6 or *1/*28.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Time to treatment failure
Progression-free survival
Overall survival
R0 resection rate
Relative dose intensity
Incidence of adverse events
Early tumor shrinkage
Deepness of response
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
Patients receive FOLFOXIRI plus bevacizumab [L-OHP: 85 mg/sq.m., CPT-11: 165 mg/sq.m., 5-FU(c.i.v.): 3,200 mg/sq.m., l-LV: 200 mg/sq.m., bevacizumab: 5 mg/kg]. The treatment will be repeated every 2 weeks, for up to 12 cycles, unless the disease progression, unacceptable toxicity, tumor resection or consent withdrawal.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed adenocarcinoma of the colon or rectum.
2. Unresectable or recurrent colorectal cancer patient.
3. One or more measurable lesion in RECIST ver.1.1 criteria.
4. No prior chemotherapy, immunotherapy, and radiotherapy.
5. Life expectancy at least 3 months.
6. Patients who harbor UGT1A1*1/*1, *1/*6 or *1/*28.
7. ECOG performance status of =<1.
8. Vital organ functions (listed below) are preserved within 14 days prior to entry.
WBC: >= 3,000 per cubic millimeter
Neu: >= 1,500 per cubic millimeter
PLT: >= 100,000 per cubic millimeter
AST and ALT: <= 100 IU/L
, <= 150 IU/L in cases with liver metastasis
T-bil: <= 2.0 mg/dL
Serum creatinine: <= 1.50 mg/dL
Proteinuria: <= 1+
PT-INR: < 1.5
9. Written informed consent.
Key exclusion criteria
1. Vermiform appendix cancer and proctos cancer.
2. Administration of blood products/ G-CSF, and blood transfusion within 14 days.
3. Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval.
4. HBs-Ag(+), or HCV-Ab(+).
5. History of severe allergy.
6. Sensory alteration or paresthesia interfering with function.
7. Prior radiotherapy for ilium and abdomen.
8. Infectious disease.
9. Uncontrolled diarrhea.
10. Ileus or bowel obstruction.
11. Interstitial lung disease or pulmonary fibrosis.
12. Malignant coelomic fluid required drainage.
13. Administration of atazanavir sulfate.
14. Heart disease to be clinically problem.
15. Major surgical procedure or intestinal resection within 28 days prior to enrollment or colostomy within 14 days prior to enrollment.
16. Known brain metastasis or strongly suspected of brain metastasis.
17. History of a thromboembolic disease.
18. Receiving anti-platelet drugs.
19. Poorly controlled gastrointestinal ulcer.
20. History of intestinal perforation within 12 months.
21. Poorly controlled hypertension.
22. Poorly controlled diabetes mellitus.
23. Severe mental disorders.
24. Women's pregnant or nursing, men/women who want to give birth or no intention to contraception.
25. Any other cases who are regarded as inadequate for study enrollment by investigators.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsunori Shinozaki, Tomohiro Nishina |
Organization
Hiroshima Prefectural Hospital, National Hospital Organization Shikoku Cancer Center
Division name
Division of Clinical Oncology, Department of Gastrointestinal Medical Oncology
Zip code
Address
1-5-54, Ujina-kanda, Minami-ku, Hiroshima, 734-8530, Kou 160 Minamiumemotomachi, Matsuyama, Ehime 791-0280
TEL
082-254-1818
k-shinozaki@hph.pref.hiroshima.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masami Yamauchi |
Organization
Hiroshima Prefectural Hospital
Division name
Division of Clinical Oncology
Zip code
Address
1-5-54, Ujina-kanda, Minami-ku, Hiroshima, 734-8530
TEL
082-254-1818
Homepage URL
mt.28@nifty.com
Sponsor or person
Institute
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2015 | Year | 04 | Month | 19 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 11 | Day |
Last modified on
| 2020 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019805
