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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008298
Receipt No. R000009444
Scientific Title Phase II trial of bi-weekly cetuximab plus mFOLFOX6 or cetuximab plus mFOLFIRI for unresectable advanced or recurrent KRAS wild type colorectal cancer (T-CORE1201)
Date of disclosure of the study information 2012/06/29
Last modified on 2020/07/07

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Basic information
Public title Phase II trial of bi-weekly cetuximab plus mFOLFOX6 or cetuximab plus mFOLFIRI for unresectable advanced or recurrent KRAS wild type colorectal cancer (T-CORE1201)
Acronym Phase II trial of bi-weekly cetuximab plus mFOLFOX6 or cetuximab plus mFOLFIRI for unresectable advanced or recurrent KRAS wild type colorectal cancer (T-CORE1201)
Scientific Title Phase II trial of bi-weekly cetuximab plus mFOLFOX6 or cetuximab plus mFOLFIRI for unresectable advanced or recurrent KRAS wild type colorectal cancer (T-CORE1201)
Scientific Title:Acronym Phase II trial of bi-weekly cetuximab plus mFOLFOX6 or cetuximab plus mFOLFIRI for unresectable advanced or recurrent KRAS wild type colorectal cancer (T-CORE1201)
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Primary endpoint is to evaluate median progression free survival (PFS) of cetuximab plus mFOLFOX6 or cetuximab plus mFOLFIRI as second line therapy in unresectable advanced or recurrent KRAS wild type colorectal cancer patients. Secondary endpoint is to estimate overall response rate (ORR) and the frequency and grades of adverse effects.
In addition, the correlation between the clinical efficacy of chemotherapy and the biomarker in tissue specimen of patients participating in this study are evaluated. Further, to verify or predictable about the effectiveness of cetuximab by sub-type classification by comprehensive gene expression analysis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Median progression free survival (PFS)
Key secondary outcomes Overall response rate (ORR) and the frequency and grades of adverse effects.

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 Patients who received L-OHP based chemotherapy as 1st line therapy are allocated bi-weekly cetuximab plus mFOFIRI. Patients who received CPT-11 based chemotherapy as 1st line therapy are allocated bi-weekly cetuximab plus mFOLFOX. Cetuximab is administered by 2 hours infusion before mFOLFOX or mFOFIRI. mFOLFOX: 85 mg/m2 of oxaliplatin, 200 mg/m2 of l-leucovorin, 400 mg/m2 of 5-FU by rapid intravenous (IV) infusion on day 1 and 2,400 mg/m2 of 5-FU for 46 h by continuous IV infusion as a 2-week course.
mFOLFIRI: 150 mg/m2 of irinotecan, 200 mg/m2 of l-leucovorin, 400 mg/m2 of 5-FU by rapid intravenous (IV) infusion on day 1 and 2,400 mg/m2 of 5-FU for 46 h by continuous IV infusion as a 2-week course.
The treatment was continued until the criteria to discontinue the trial were met.
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 The criteria for eligibility were as follows:
1) Written informed consent was obtained from the patient for trial participation.
2) Patient of pathologically defined colorectal adenocarcinoma.
3) Surgical specimen or biopsy specimens are available.
4) WT KRAS is confirmed.
5) Age 20 or older.
6) Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
7) One or more measurable lesions based on the RECIST (ver 1.1) are confirmed by CT within 30 days before registration. In case of patient who received radiation therapy, new measurable lesions after radiation therapy or measurable lesions out of radiation field.
8) Patient who received L-OHP based or CPT-11 based chemotherapy and confirmed refractory or intolerable. In case of patient who receieved adjuvant chemotherapy more than six months since last administration, the adjuvant chemotherapy is not defined as 1st line chemotherapy.
9) Following interval from previous treatments (4 weeks from radiations, 2weeks from a operation with some organ resection(excluding colostomy), 2 weeks from chemotherapy, 2 weeks from hormone therapy and immunotherapy, 2 weeks from cytokine therapy and BRM drugs, 4 weeks from other clinical trial).
10) Survival is expected to be at least 60 days or more.
11) No obvious organ failures and satisfy the following laboratory data within 15 days before registration:
1. Neutrophiles: 1,500/mm3 or more.
2. Hb: 8.0 g/dl or more.
3. Platelets: 100,000/mm3 or more.
4. Total bilirubin: less than 2.0 mg/dl.
5. AST(GOT) and ALT(GPT): 100 IU/L or less.
6. Serum creatinine: 1.50 mg/dL or less.
Key exclusion criteria The exclusion criteria were as follows;
1) Patients who treated transfusion, such as blood products and G-CSF treatment within 7 days before registration.
2) History of severe drug hypersensitivity or allergy.
3) In case of receiving bi-weekly cetuximab plus mFOLFOX, history of severe drug hypersensitivity or allergy with L-OHP.
4) Obvious infection and inflammation (fever with 38.0 degree or higher).
5) Poorly controlled hypercalcemia.
6) Poorly controlled hypertension.
7) Poorly controlled diabetes.
8) Obvious abnormality in ECG or heart disease becomes a clinical problem.
9) Severe pulmonary disease such as interstitial pneumonia, pulmonary fibrosis, severe emphysema.
10) Patient with a mental disorder becomes a clinical problem or a history of a CNS disorder.
11) Active GI tract bleeding.
12) Patient who need drainage of peritoneal, pleural or pericardial effusion.
13) Patient who have wide range bone metastases.
14) Patient who has or clinically suspicious for brain metastasis.
15) Chronic diarrhea may disturb the daily life(watery diarrhea).
16) Gastrointestinal paresthesia and bowel obstruction.
17) Active double cancer.
18) Patients who are treated with atazanavir sulfate.
19) Grade 3 or more hypersensitivity with monoclonal antibody.
20) Patients who were treated with EGFR or EGFR pathway targeted therapy.
21) Patients who are addicted to alcohol or drugs.
22) HBs antigen positive or active hepatitis B.
23) Peripheral sensory neuropathy interfering with daily life.
24) Women who are pregnant, may be pregnant, wish to become pregnant or are lactating. Men who wish their partner to become pregnant.
25) Attending physician determines that the case was inappropriate as the subject of this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Chikashi
Middle name
Last name Ishioka
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Department of Clinical Oncology
Zip code 980-8575
Address 4-1, Seiryo-Machi, Aoba-ku, Sendai City, Miyagi
TEL 022-717-8543
Email chikashi@tohoku.ac.jp

Public contact
Name of contact person
1st name Masanobu
Middle name
Last name Takahashi
Organization Tohoku Clinical Oncoogy, Research and Education Society(T-CORE)
Division name Administration Office
Zip code 980-8575
Address 4-1 Seiryo-machi, Aoba-ku, Sendai,9808575, Japan
TEL 0227178599
Homepage URL https://t-core.jp
Email toruishi@t-core.jp

Sponsor
Institute Tohoku Clinical Oncoogy, Research and Education Society(T-CORE)
Institute
Department

Funding Source
Organization Tohoku Clinical Oncoogy, Research and Education Society(T-CORE)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University
Address 1-1 Seiryo-machi, Aoba-ku, Sendai 9808574, Japan
Tel 022(717)7000
Email med-kenkyo@bureau.tohoku.ac.jp

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

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 29 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 66
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
2012 Year 03 Month 10 Day
Date of IRB
2012 Year 02 Month 27 Day
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 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
2012 Year 06 Month 29 Day
Last modified on
2020 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009444

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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