UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027014 |
|---|---|
| Receipt number | R000030974 |
| Scientific Title | The follow up study of "Phase l / ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type (JACCRO CC-06)". |
| Date of disclosure of the study information | 2017/04/18 |
| Last modified on | 2019/03/08 10:14:22 |
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Basic information
Public title
The follow up study of "Phase l / ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type (JACCRO CC-06)".
Acronym
JACCRO CC-06 B
Scientific Title
The follow up study of "Phase l / ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type (JACCRO CC-06)".
Scientific Title:Acronym
JACCRO CC-06 B
Region
| Japan |
Condition
Condition
metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study to evaluate the overall survival of the patients with EGFR positive and KRAS wild type who registered JACCRO CC-06 study treated by S-1/Oxaliplatin/cetuximab.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall Survival (OS)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) 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.
(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
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Ichikawa |
Organization
Showa University Fujigaoka Hospital
Division name
Division of Medical Oncology and Palliative Medicine
Zip code
Address
1-30 Fujigaoka, Aoba-ku, Yokohama-shi, Kanagawa 224-8503, Japan
TEL
045-971-1151
wataru@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Fujii |
Organization
Japan Clinical Cancer Research Organization
Division name
Office
Zip code
Address
1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9882
Homepage URL
cc06.dc@jaccro.or.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
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
神戸市立医療センター中央市民病院(愛知県）、昭和大学横浜市北部病院（神奈川県）、岡山ろうさい病院（岡山県）、埼玉医科大学国際医療センター（埼玉県）、千葉県がんセンター（千葉県）、医療法人薫風会佐野病院（兵庫県）、近畿大学医学部奈良病院（奈良県）、一般財団法人甲南会甲南病院（兵庫県）、高知医療センター（高知県）、神戸大学医学部附属病院（兵庫県）、日本大学医学部附属板橋病院（東京都）、函館五稜郭病院（北海道）、姫路赤十字病院（兵庫県）、兵庫県立がんセンター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 18 | 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
| 2017 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 11 | Day |
Other
Other related information
The median survival time (MST) is not reached, because the 33 of the 59 patients who enrolled JACCRO CC-06 study is still alive at the end of the planned follow-up period of 2 years. We planned additional follow up of these patients to complete the actual MST.
Management information
Registered date
| 2017 | Year | 04 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030974
| 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 |
