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UMIN-CTR Clinical Trial |
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Name: | 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 | 2020/05/21 |
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 |
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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 | 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 | 1. Overall survival (OS)
2. OS for Participants with Left-sided Tumors |
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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cancer Center Hospital East | ||||||
Division name | Department of Gastrointestinal Oncology | ||||||
Zip code | 277-8577 | ||||||
Address | 6-5-1 Kashiwanoha, Kashiwa, Chiba | ||||||
TEL | 04-7133-1111 | ||||||
protocol@paradigm-study.jp |
Public contact | |||||||
Name of contact person |
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Organization | Takeda Pharmaceutical Company Limited | ||||||
Division name | Contact for Clinical Trial Information | ||||||
Zip code | 103 - 8668 | ||||||
Address | https://www.takeda.com/jp/who-we-are/contact-us/ | ||||||
TEL | 06-6204-2111 | ||||||
Homepage URL | |||||||
protocol@paradigm-study.jp |
Sponsor | |
Institute | National Cancer Center Hospital East |
Institute | |
Department |
Funding Source | |
Organization | Takeda Pharmaceutical Company Limited |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
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IRB Contact (For public release) | |
Organization | National Cancer Center Hospital East Certified Review Board |
Address | 6-5-1 Kashiwanoha Kashiwa-shi Chiba,Japan, Chiba |
Tel | 04-7133-1111 |
ncche-irb@east.ncc.go.jp |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | JapicCTI-142731 |
Org. issuing International ID_1 | JAPIC |
Study ID_2 | jRCTs031180246 |
Org. issuing International ID_2 | Japan registry of clinical trials |
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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Recruitment status | No longer recruiting | ||||||
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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=R000019460 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |