NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-142668

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedColorectal carcinoma
Date of first enrollment17/9/2014
Target sample size164
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : mFOLFOX6 + panitumumab combination therapy, Protocol Treatment [1] and Group A, Protocol treatment [2] Dosage And administration of the intervention : Protocol Treatment [1] mFOLFOX6 + panitumumab combination therapy [oxaliplatin (OXA): 85 mg/m2/day 1; levofolinate calcium (l-LV): 200 mg/m2/day 1; bolus 5-FU: 400 mg/m2/day 1; infusional 5-FU: 2400 mg/m2/day 1-3; panitumumab: 6 mg/kg] once every two weeks, 6 cycles Protocol Treatment [2] Group A mFOLFOX6 + panitumumab combination therapy, once every two weeks Control intervention name : mFOLFOX6 + panitumumab combination therapy, Protocol Treatment [1] followed by 5-FU/LV + panitumumab combination therapy, Group B, Protocol treatment [2] Dosage And administration of the control intervention : Protocol Treatment [1] mFOLFOX6 + panitumumab combination therapy [oxaliplatin (OXA): 85 mg/m2/day 1; levofolinate calcium (l-LV): 200 mg/m2/day 1; bolus 5-FU: 400 mg/m2/day 1; infusional 5-FU: 2400 mg/m2/day 1-3; panitumumab: 6 mg/kg] once every two weeks, 6 cycles Protocol Treatment [2] Group B 5-FU/LV + panitumumab combination therapy [levofolinate calcium (l-LV): 200 mg/m2/day 1; bolus 5-FU: 400 mg/m2/day 1; infusional 5-FU: 2400 mg/m2/day 1-3; panitumumab: 6 mg/kg] once every two weeks

Outcome(s)

Primary Outcome<Efficacy> Progression Free Survival rate (PFS rate) at 9 months after randomization Primary timeframe: At 9 months after randomization The 9-month PFS rate is defined as the number of subjects who had not progressed or died prior to 9 months from the date of randomization, divided by the number of subjects in each arm.
Secondary Outcome<Efficacy> -Progression Free Survival (PFS) -Overall survival (OS) -Response rate (RR) -Time to treatment failure (TTF) <Safety> -Frequency of adverse events Secondary timeframe <Efficacy> -PFS: From the day of randomization (Day 0) until the day of judgment of exacerbation from the day of randomization, or until death by all causes, whichever comes from randomization to disease progression or until death by all causes. -OS: From the day of randomization (Day 0) until death by all causes. -RR: After randomization -TTF: From the date of randomization (counted as Day 0) to the date of judgment of discontinuation of protocol treatment, the date of judgment of progression, or the date of death for all causes, whichever has come earliest. <Safety> After initiation of protocol treatment after randomization <Efficacy> -PFS: The period from the day of randomization (Day 0) until the day of judgment of exacerbation from the day of randomization, or until death by all causes, whichever comes earlier. -OS: The time from the date of randomization to the date of death by all causes. -PR: The percentage of subjects who have shown complete response or partial response as the best overall response in RECIST ver 1.1 after randomization. The overall response will be complete response, followed by partial response, stable disease, progression, and nonevaluable in this order. -TTF: The period from the date of randomization (counted as Day 0) to the date of judgment of discontinuation of protocol treatment, the date of judgment of progression, or the date of death for all causes, whichever has come earliest <Safety> -Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The frequencies of all adverse events which developed after initiation of protocol treatment after randomization will be tabulated by type and seriousness, and causal relationship to panitumumab.

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderBOTH
Include criteriaInclusion criteria for enrollment: (1) Patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer) (2) Patients with measurable lesion(s) according to the RECIST ver. 1.1 (3) Patients who have not received chemotherapy for colorectal cancer. Patients who experience relapse more than 6 months after the final dose of perioperative adjuvant chemotherapy with fluoropyrimidine agents may be enrolled. (4) Aged>= 20 years at the time of informed consent (5) Patients classified as KRAS wild-type. However, the criteria will be changed to all patients who are verified to be of KRAS and NRAS wild-type when the KRAS and NRAS tests come to be covered by National Health Insurance, and the tests become feasible at medical institutions. (6) Patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment 1) Neutrophil count >= 1.5 x 103/microL 2) White blood cell count >= 3.0 x 103/microL 3) Platelet count >= 10.0 x 104/microL 4) Hemoglobin >= 9.0 g/dL 5) Total bilirubin >= 2.0 mg/dL 6) AST >= 100 U/L (<= 200 U/L if liver metastases are present) 7) ALT >= 100 U/L (<= 200 U/L if liver metastases are present) 8) Serum creatinine <= 1.5 mg/dL (7) Patients who are assessed at Eastern Cooperative Oncology Group (ECOG) performance status (P.S.) of 0 or 1 (8) Life expectancy of >= 6 months after enrollment (9) Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment Inclusion criteria for randomization: (1) Patients who have received 6 cycles of mFOLFOX6 + panitumumab combination therapy (2) Patients who are assessed at ECOG P.S. of 0-1 in the 6th cycle. (3) Patients for whom PD or not evaluable has been denied on the RECIST based on imaging tests conducted after the day of administration in the 6th cycle within 14 days (2 weeks).
Exclude criteriaExclusion criteria for enrollment: (1) Radiotherapy received for a measurable lesion (2) Radiotherapy received within 28 days (4 weeks) prior to enrollment for a lesion other than measurable lesions (3) Known brain metastasis or strongly suspected of brain metastasis (4) 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 (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.). (5) Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.) (6) Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy (7) Active hemorrhage requiring blood transfusion (8) Disease requiring systemic steroids for treatment (excluding topical steroids) (9) Intestinal resection and colostomy within 14 days (2 weeks) prior to enrollment (10) History or obvious and extensive computerized tomography findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.) (11) Serious drug hypersensitivity (12) Local or systemic active infection requiring treatment, or fever indicating infection (13) Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhea (incapacitating symptoms despite adequate treatment) (14) Active hepatitis B and/or active hepatitis C (15) Known human immunodeficiency virus infection (16) Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study Exclusion criteria for randomization: (1) Patients in whom interstitial pneumonia has been newly diagnosed during the period from registration to randomization (2) Patients who have received radiotherapy during the period from registration to randomization (3) Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study

Related Information

Contact

public contact
Name Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation
scientific contact
Name
Address
Telephone
E-mail
Affiliation