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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016776
Receipt No. R000019460
Scientific Title A phase III, randomized, controlled study of mFOLFOX6 + bevacizumab combination therapy versus mFOLFOX6 + panitumumab combination therapy in chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer
Date of disclosure of the study information 2015/03/23
Last modified on 2017/06/14

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Basic information
Public title A phase III, randomized, controlled study of mFOLFOX6 + bevacizumab combination therapy versus mFOLFOX6 + panitumumab combination therapy in chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer
Acronym PARADIGM study
Scientific Title A phase III, randomized, controlled study of mFOLFOX6 + bevacizumab combination therapy versus mFOLFOX6 + panitumumab combination therapy in chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer
Scientific Title:Acronym PARADIGM study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 o verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Overall survival (OS)
Key secondary outcomes Efficacy
Progression-free survival (PFS)
Response rate (RR)
Duration of response (DOR)
Percentage of subjects treated with surgical resection after chemotherapy(complete resection)
Safety
Percentage of subjects with adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 mFOLFOX6 + panitumumab
Interventions/Control_2 mFOLFOX6 + bevacizumab
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
80 years-old >
Gender Male and Female
Key inclusion criteria (1)Investigator and subinvestigator judge a candidate is understand clinical trial and comply this protocol.
(2)Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment
(3)Aged 20 to <80 years at the time of informed consent
(4)Patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer)
(5)Patients with lesion(s) that can be evaluated.
(6)Patients who have not received chemotherapy for colorectal cancer. Patients who experience relapse more than 24 weeks (168 days) after the final dose of perioperative adjuvant chemotherapy* with fluoropyrimidine agents may be enrolled.
*: Patients who have received perioperative adjuvant chemotherapy including oxaliplatin are excluded.
(7)Patients classified as KRAS/NRAS wild-type by KRAS/NRAS testing.
KRAS: EXON2 (codon 12, 13), EXON3 (codon 59, 61), EXON4 (codon 117, 146)
NRAS: EXON2 (codon 12, 13), EXON3 (codon 59, 61),EXON4 (codon 117, 146)
(8)Patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment
1)Neutrophil count >= 1.5x103/micro;L
2)Platelet count >= 1.0x104/micro;L
3)Hemoglobin >= 9.0 g/dL
4)Total bilirubin <= 2.0 mg/dL
5)AST <= 100 IU/L (200 IU/L if liver metastases are present)
6)ALT <= 100 IU/L (200 IU/L if liver metastases are present)
7)Serum creatinine <= 1.5 mg/dL
8)PT-INR < 1.5 (< 3.0 for patients treated with oral warfarin)
9)Satisfies at least one of these conditions
(i) Urine protein (dip stick method) <= 1+
(ii) UPC (urine protein creatinine) ratio <= 1.0
(iii) Urinary protein <= 1000mg/ 24hours
(9)ECOG performance status (PS) of 0 or 1
(10)Life expectancy of >= 3 months (90 days) after enrollment
Key exclusion criteria (1)Radiotherapy received within 4 weeks (28 days) prior to enrollment
(2)Known brain metastasis or strongly suspected of brain metastasis
(3)Synchronous cancers or metachronous cancers with a disease-free period of ; 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection.
(4)Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.)
(5)Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy
(6)Nonhealing surgical wound (excluding implanted venous reservoirs)
(7)Active hemorrhage requiring blood transfusion
(8)Disease requiring systemic steroids for treatment (excluding topical steroids)
(9)The patient who has placed colonic stent
(10)Intestinal resection within 4 weeks prior to enrollment or colostomy within 2 weeks prior to enrollmentt
(11)History or obvious and extensive CT findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.)
(12)patients with unstable angina, myocardial infarction, cerebral hemorrhage, and have a arterial thromboembolism such as cerebral infarction, or history within 24 weeks (168 days) (except for asymptomatic lacunar infarction)
(13)Serious drug hypersensitivity
(14)Local or systemic active infection requiring treatment, or fever indicating infection
(15)NYHA class II or higher heart failure or serious heart disease
(16)Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhoea (incapacitating symptoms despite adequate treatment)
(17)Poorly controlled hypertension
(18)Poorly controlled diabetes mellitus
(19)Active hepatitis B
(20)Known HIV infection
(21)Peripheral neuropathy of; Grade 2 by CTCAE (Japanese edition JCOG version 4.03)
(22)Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Muro / Takayuki Yoshino
Organization Aichi Cancer Center / National Cancer Center Hospital East
Division name Department of Clinical Oncology / Department of Gastrointestinal Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku Nagoya / 6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL 03-6226-8880
Email protocol@paradigm-study.jp

Public contact
Name of contact person
1st name
Middle name
Last name Contact for Clinical Trial Information
Organization Takeda Pharmaceutical Company Limited
Division name Contact for Clinical Trial Information
Zip code
Address 12-10 Nihonbashi 2-chome Chuo-ku Tokyo Japan
TEL 03-3278-2111
Homepage URL
Email protocol@paradigm-study.jp

Sponsor
Institute Takeda Pharmaceutical Company Limited
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JapicCTI-142731
Org. issuing International ID_1 JAPIC
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 23 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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 11 Day
Last modified on
2017 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019460

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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