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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001668 |
Receipt No. | R000001978 |
Scientific Title | Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-refractory patients with EGFR-positive advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on KRAS mutation status (T-CORE0801) |
Date of disclosure of the study information | 2009/01/31 |
Last modified on | 2015/07/29 |
Basic information | ||
Public title | Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-refractory patients with EGFR-positive advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on KRAS mutation status (T-CORE0801) | |
Acronym | Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-resisitant advanced and/or metastatic colorectal cancer with KRAS mutation analysis (T-CORE0801) | |
Scientific Title | Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-refractory patients with EGFR-positive advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on KRAS mutation status (T-CORE0801) | |
Scientific Title:Acronym | Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-resisitant advanced and/or metastatic colorectal cancer with KRAS mutation analysis (T-CORE0801) | |
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Condition | |||
Condition | 3rd line or later therapy for unresectable advanced and/or recurrent colorectal cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | YES |
Objectives | |
Narrative objectives1 | We confirm safety and efficacy of cetuximab plus irinotecan as a 3rd line or later therapy in patients with EGFR positive unresectable advanced and/or recurrenct colorectal cancer. We also examine KRAS mutation as a prospective analysis and compare the safety and efficacy of cetuximab plus irinotecan between KRAS wild-type and mutant group. As an accompanied study, we further examine mutations in BRAF, PIK3CA and PTEN, microsatellite instability, and two SNPs in Fcgamma receptor genes (FcgammaRIIa-H131R and FcgammmaRIIIa-V158F) and compare the safety and efficacy of cetuximab plus irinotecan. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | response rate |
Key secondary outcomes | progression free survival (PFS), overall survival(OS) and 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 | Diagnosis | |
Type of intervention |
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Interventions/Control_1 | cetuximab 400 mg/m2 given as 2 hours infusion for the first time, 250mg/m2 as 1 hour infusion for the second time or later. Irinotecan 100mg/m2 repeated every week followed by one week rest or Irinotecan 150mg/m2 repeated every two weeks.
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The criteria for eligibility were histologically proven EGFR positive colorectal cancer of; an age of 20 or older; with an unresectable primary tumor or with one or more unresectable metatatic tumor(s); more than two privious treatment by FOLFOX or FOLFIRI regimen; with performance status (ECOG) 0, 1 or 2; the following interval from previous treatments (4 weeks from radiations, 2weeks from a operation with some organ resection, 2 weeks from chemotherapy, 4 weeks from other clinical trial), measurable lesions based on the RECIST; and adequate organ function (a neutrophil count of 1500 or more per cubic millimeter ; a platelet count of at least 100,000 per cubic millimeter; hemoglobin levels of more than 8.0 g per deciliter ;aspartate
aminotransferase and alanine aminotransferase levels of 100 or less international unit per litter; a total bilirubin level of no more than 2.0 mg per deciliter; and a serum creatinine level of no more than 1.5 mg per deciliter; expected more than 2 months prognosis; with a written informed consent for this study |
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Key exclusion criteria | The exclusion criteria were symptomatic metastatic brain tumor, uncontrolled massive pleural or abdominal effusion, previous meningitis carcinomatosis, uncontrolled epilepsy, critical mental disturbance, central nervous system disorder, uncontrolled diabtes mellitus, uncontrolled hypertension, active infection treated with antibiotics, antifungal or antiviral drugs, bleeding tendency, symptomatic coagulation abnormality, acute pneumonia, interstitial pneumonitis or pulmonary fibrosis, chronic disease required the treatment with steroid or immune-suppressing drug, diarrhea; with complication of paralytic intestine, bowel obstraction (ileus), previous history of herpersensitivity (Grade 3 or severe) against monoclonal antibody drug, previous history of herpersensitivity against irinotecan, pevious therapy with inhibitor of EGF signal transduction or inhibitor of EGFR, treated with Atazanavir Sulfate, active double cancer within 5 years, Grade 3 or severe neural disturbance, Grade III or IV by NYHA classification or sever cardiac disease within 6 months.
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Institute of Development, Aging and Cancer, Tohoku University | ||||||
Division name | Department of Clinical Oncology | ||||||
Zip code | |||||||
Address | 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan | ||||||
TEL | 022-7171-8547 | ||||||
hshimoda@idac.tohoku.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | NPO T-CORE (Tohoku Clinical Oncology Research and Education Society) | ||||||
Division name | Office | ||||||
Zip code | |||||||
Address | 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan | ||||||
TEL | 022-717-8599 | ||||||
Homepage URL | http://www.T-CORE.JP | ||||||
t-core-admin@umin.ac.jp |
Sponsor | |
Institute | NPO T-CORE (Tohoku Clinical Oncology Research and Education Society) |
Institute | |
Department |
Funding Source | |
Organization | NPO T-CORE (Tohoku Clinical Oncology Research and Education Society) |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | http://www.t-core.jp |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.karger.com/Article/FullText/360989 |
Number of participants that the trial has enrolled | |
Results | Results:KRAS mutations were detected in 31.7% of 41 eligible patients. The RR to cetuximab plus irinotecan therapy was found to be 17.9 and 0% in the KRAS wild-type and mutant subgroups, respectively. Conclusion: Despite the identification of a lower-than-expected RR to treatment by the KRAS wild-type subgroup, KRAS mutation status appears to be a useful predictive marker of response to cetuximab plus irinotecan therapy in Japanese mCRC patients. |
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Recruitment status | Completed | ||||||
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Other | |
Other related information | As a prospective study, mutation analysis of KRAS, BRAF, PIK3CA, and PTEN genes, microsatellite instability (MSI) and two common SNPs of Fc gamma receptor genes will be examined for all enrolled patients |
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=R000001978 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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