UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007022 |
|---|---|
| Receipt number | R000008284 |
| Scientific Title | Phase l and Phase ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type |
| Date of disclosure of the study information | 2012/01/06 |
| Last modified on | 2016/11/24 15:00:36 |
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Basic information
Public title
Phase l and Phase ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
Acronym
JACCRO CC-06 study
Scientific Title
Phase l and Phase ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
Scientific Title:Acronym
JACCRO CC-06 study
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine MTD and RD in Phase I and to evaluate the efficacy and safety of TS-1+oxaliplatin+cetuximab as first line in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: Maximum Tolerated Dose, Recommended Dose
Phase II: Response Rate
Key secondary outcomes
Phase I: Safety, Response Rate
Phase II: Overall Survival, Progression Free Survival, 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
S-1 +oxaliplatin (SOX) + cetuximab
Cetuximab: loding dose 400 mg/m2, 250 mg/m2/week
L-OHP: 75-130 mg/m2 tri-weekly
S-1: 80 mg/m2 (80-120 mg/day)
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with histologically proven colorectal cancer
2. Metastatic colorectal cancer with EGFR expressed
3. KRAS wild type in codon 12, 13
4. Presence of measurable lesion (RECIST Ver.1.)
5. No prior chemotherapy for unresectable primary tumor, metastases and lymph node metastasis. No primar therapy including surgery for recurrent that should be the first relapse after surgery for primary or metastases tumors
6. ECOG Performance Status (PS) 0-1
7. Age over 20 years (Age between 20 to 79 years in Phase I)
8. Life expectancy of more than 3 months
9. Oral food intake possible
10. Patients have enough organ function for study treatment
11. Written informed consent
Key exclusion criteria
1. Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
2. Symptomatic brain metastases
3. Severe infectious disease
4. Interstitial lung disease or pulmonary fibrosis
5. Comorbidity or history of heart failure
6. Sensory alteration or paresthesia interfering with function
7. Large quantity of pleural, abdominal or cardiac effusion
8. Severe comorbidity (renal failure, liver failure, hypertension, etc)
9. Prior radiotherapy for primary and metastases tumors
10. Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
11. History of severe allergy
12. History of allergy for L-OHP and other platinating agent
13. Prior treatment of cetuximab or L-OHP or TS-1
14. Administration of flucytosine
15. Any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Ichikawa |
Organization
National Defense Medical College Hospital
Division name
Department of Clinical Oncology
Zip code
Address
3-2 Namiki, Tokorozawa-shi, Saitama, Japan 359-8513
TEL
04-2995-1511
wataru@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wataru Ichikawa |
Organization
National Defense Medical College Hospital
Division name
Department of Clinical Oncology
Zip code
Address
3-2 Namiki, Tokorozawa-shi, Saitama, Japan 359-8513
TEL
04-2995-1511
Homepage URL
http://www.jaccro.com/
wataru@ndmc.ac.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization
Institute
Department
Personal name
Funding Source
Organization
Japan Clinical Cancer Research Organization
Organization
Division
Category of Funding Organization
Non profit foundation
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
防衛医科大学校病院（埼玉県）、埼玉医科大学国際医療センター（埼玉県）、神戸市立医療センター中央市民病院（兵庫県）、がん・感染症センター都立駒込病院（東京都）、岐阜大学医学部附属病院（岐阜県）、慈泉会相澤病院（長野県）、昭和大学横浜市北部病院（神奈川県）、駿河台日本大学病院（東京都）、千葉県がんセンター（千葉県）、日本大学医学部附属板橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 06 | Day |
Last modified on
| 2016 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008284
