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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000031621 |
Receipt No. | R000036095 |
Scientific Title | Retrospective analysis of randomized phase II trial (WJOG6210G) of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab to evaluate the association of survival time and treatment efficacy (early tumor shrinkage, depth of response and best overall response) at each arm |
Date of disclosure of the study information | 2018/03/07 |
Last modified on | 2018/04/12 |
Basic information | ||
Public title | Retrospective analysis of randomized phase II trial (WJOG6210G) of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab to evaluate the association of survival time and treatment efficacy (early tumor shrinkage, depth of response and best overall response) at each arm | |
Acronym | Retrospective analysis for predictive factor of FOLFIRI+Pmab vs FOLFIRI+BV as second-line for colorectal cancer | |
Scientific Title | Retrospective analysis of randomized phase II trial (WJOG6210G) of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab to evaluate the association of survival time and treatment efficacy (early tumor shrinkage, depth of response and best overall response) at each arm | |
Scientific Title:Acronym | Retrospective analysis for predictive factor of FOLFIRI+Pmab vs FOLFIRI+BV as second-line for colorectal cancer | |
Region |
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Condition | |||
Condition | Colorectal cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the association of survival time (progression-free survival, overall survival) and treatment efficacy (early tumor shrinkage, depth of response and best overall response) at each arm (FOLFIRI+BV, FOLFIRI+Pmab) for metastatic colorectal cancer as second-line chemotherapy. |
Basic objectives2 | Others |
Basic objectives -Others | To explore the predictive factor of treatment |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | To evaluate the association of survival time (progression-free survival, overall survival) and treatment efficacy (early tumor shrinkage, depth of response and best overall response) at each arm (FOLFIRI+BV, FOLFIRI+Pmab) for metastatic colorectal cancer as second-line chemotherapy. |
Key secondary outcomes | To evaluate the association of known data of ligand protein level and period of BV treatment during first-line chemotherapy.
To evaluate the association of treatment efficacy and patient characteristics. To evaluate the association of survival time and patient characteristics. To evaluate the association of survival time and known data of ligand protein level. To evaluate the association of survival time and VEGF-D which is measured by using residual sample, treatment efficacy and VEGF-D, and patient characteristics and VEGF-D. |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
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Blinding | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | Patients who were enrolled in WJOG6210G study | |||
Key exclusion criteria | None | |||
Target sample size | 117 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | St. Marianna University School of Medicine | ||||||
Division name | Department of Clinical Oncology | ||||||
Zip code | |||||||
Address | 2-16-1, Sugao, Miyamake-ku, Kawasaki | ||||||
TEL | 044-977-8111 | ||||||
n2izawa@marianna-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | West Japan Oncology Group | ||||||
Division name | WJOG datacenter | ||||||
Zip code | |||||||
Address | Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN | ||||||
TEL | 06-6633-7400 | ||||||
Homepage URL | |||||||
datacenter@wjog.jp |
Sponsor | |
Institute | West Japan Oncology Group |
Institute | |
Department |
Funding Source | |
Organization | Japan Agency for Medical Research and Development |
Organization | |
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Category of Funding Organization | Japanese Governmental office |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Other | |
Other related information | To explore the predictive factor of treatment |
Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036095 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |