UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015152 |
|---|---|
| Receipt number | R000017623 |
| Scientific Title | Phase II study of first-line treatment by FOLFOXIRI+bevacizumab in patients with RAS mutant-type metastatic colorectal cancer |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2025/05/30 10:58:45 |
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Basic information
Public title
Phase II study of first-line treatment by FOLFOXIRI+bevacizumab in patients with RAS mutant-type metastatic colorectal cancer
Acronym
JACCRO CC-11 study
Scientific Title
Phase II study of first-line treatment by FOLFOXIRI+bevacizumab in patients with RAS mutant-type metastatic colorectal cancer
Scientific Title:Acronym
JACCRO CC-11 study
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of FOLFOXIRI+bevacizumab in patients with RAS mutant-type metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Progression free survival
Overall Survival
Safety
Early Tumor Shrinkage
Deepness of Response
Correlation between biomarkers and therapeutic effects and prognosis
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
FOLFOXIRI +/- bevacizumab (Until 12 course)
5-FU + levoforinate +/- bevacitumab (After 13 course)
bevacizumab 5mg/Kg/bi-weekly
Irinotecan 150mg/m2/bi-weekly
Oxaliplatin 85mg/m2/bi-weekly
Levofolinate 200mg/m2/bi-weekly
5-FU 2400mg/m2/bi-weekly
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
| 76 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Histologically confirmed colorectal cancer. (2) KRAS mutant-type or RAS mutant-type. (3) Measurable lesion by RECIST (Ver.1.1). (4) No past history of chemotherapy. (5) Age; more than 20 years old and less than 76 years old. (6) ECOG Performance status 0-1 and in case of more than 71 years old must be PS 0. (7) Life expectancy of more than 3 months. (8) Patients have enough organ function for study treatment within 14 days before enrollment; 1) WBC>= 3,000/mm3, <12,000/mm3. 2) Neu>= 1,500/mm3. 3) PLT>= 100,000/mm3. 4) Hb>= 9.0g/dL. 5) Total bilirubin<= 1.5x ULN. 6) AST<= 2.5x ULN. 7) ALT<= 2.5x ULN. 8) Creatinine<= 1.5x ULN. 9) Proteinuria<= 1+. (9) Written informed consent.
Key exclusion criteria
(1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2) Brain metastases. (3) Infectious disease. (4) Interstitial lung disease or pulmonary fibrosis. (5) Comorbidity or history of serious heart failure. (6) History of thromboembolic events. (7) Cerebrovascular disease. (8) History of hemoptysis/hematemesis. (9) Uncontrolled hypertension.(systolic BP>180mmHg, or diastolic BP>100mmHg) (10) Sensory alteration or paresthesia interfering with function. (11) Large quantity of pleural, abdominal or cardiac effusion. (12) Severe comorbidity (renal failure, liver failure, hypertension, etc) (13) Prior radiotherapy for primary and metastases leision. (14) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (15) History of severe allergy. (16) HBs-Ag(+), or HCV-Ab(+). (17) Administration of blood products/ G-CSF, and blood transfusion within 14 days. (18) Surgical procedure or such as skin-open biopy, trauma surgery, or other more intensive surgeries within 28 days. (19) Systemaic administration of antiplatelet drug or NSAIDs. (20) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy. (21) Active peptic ulcer. (22) History of gastrointestinal perforation within 1 year. (23) Unhealed traumatic bone fracture. (24) Uncontrolled diarrhea. (25) History of organ recipient . (26) Prior bevacizumab/Irinotecan/Oxaliplatin treatment.(Adjuvant therapy by Oxaliplatin is excluded) (27) Administration of atazanavir sulfate. (28) Jaundice. (29) Ileus or bowel obstruction. (30) Any other cases who are regarded as inadequate for study enrollment by investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sekikawa |
Organization
Showa University Fujigaoka Hospital
Division name
Division of Medical Oncology and Palliative Medicine
Zip code
227-8501
Address
1-30 Fujigaoka, Aoba-ku, Yokohama-shi, Kanagawa 224-8503, Japan
TEL
045-971-1151
sekikawa@pop12.odn.ne.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Fujii |
Organization
Japan Clinical Cancer Reseach Organization (JACCRO)
Division name
Research Office
Zip code
101-0051
Address
6F Jimbocho Kyowa Bldg, 1-64-3 Kanda-Jimbocho, Chiyoda-ku, Tokyo
TEL
03-6811-0433
Homepage URL
cc11.dc@jaccro.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Reseach Organization (JACCRO)
Institute
Department
Personal name
Funding Source
Organization
Japan Clinical Cancer Reseach Organization (JACCRO)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Yakult Honsha Co., Ltd.
IRB Contact (For public release)
Organization
Japan Clinical Cancer Reseach Organization (JACCRO)
Address
6F Jimbocho Kyowa Bldg, 1-64-3 Kanda-Jimbocho, Chiyoda-ku, Tokyo
Tel
03-6811-0433
jaccro@jaccro.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs031180130
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://jrct.mhlw.go.jp/latest-detail/jRCTs031180130
Publication of results
Published
Result
URL related to results and publications
https://jrct.mhlw.go.jp/latest-detail/jRCTs031180130
Number of participants that the trial has enrolled
64
Results
Modified FOLFOXIRI plus bevacizumab regimen consisted of reduced dose of irinotecan and 5FU compared to dose of the TRIBE study. Primary endpoint of response rate was almost same as one of the TRIBE trial. The incidence of febrile neutropenia was 4.8%. Considering this, modified-FOLFOXIRI plus bevacizumab regimen is feasible and very effective regimen for Japanese patients.
Results date posted
| 2025 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age at consent was 62.5 years (Range: 36-75), and gender was 34 (54.8%) for male and 28 (45.2%) for female. PS was 0 in 57 cases (91.9%), 1 in 5 cases (8.1%), primary tumor was colon for 34 cases (54.8%), the side was left in45 cases (72.6%), while right in 17 cases (27.4%). Distant metastasis was observed in 60 of 62 patients, 48 (77.4%) of liver metastases and 19 (30.6%) of lung metastases (bilateral). As for UGT1A1 genotypes, wild type (* 1 / * 1) for 27 cases (43.5%), heterozygous type (* 1 / * 6, * 1 / * 28) for 17 cases (27.4%), homozygous type for 5 cases (8.1%).
Participant flow
A total of 64 patients were enrolled. The full analysis set consisted of 62 patients, and 63 patients were included in the safety population because 1 of the 64 patients did not meet the eligibility criteria but received the protocol treatment, and another patient did not receive any course of treatment.
Adverse events
Adverse events of Gr 3/4 were neutropenia (54%), leukopenia (28.6%), anemia (6.3%), hypokalemia (6.3%), hyponatremia (4.8%), proteinuria (3.2%), hypertension (31.7%), diarrhea (12.7%), anorexia (11.1%), nausea (7.9%), and febrile neutropenia (4.8%).
Outcome measures
Objective response rate (95% CI) and Disease control rate (95% CI) were 75.8% and 96.8%, respectively.
The result in terms of objective response rate met primary endpoint.
Median PFS was 11.86 (95%CI 9.46-14.03) months, median OS was 30.16 (95%CI 25.79-34.69), median DpR was 49.2% (-28.7-100) , and ETS was 73.8%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017623
