JACCRO CC-16

JRCT ID: jRCTs061180002

Registered date:21/12/2018

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 21/11/2018
• Target sample size: 90
• Countries of recruitment: Nothing,Japan
• Study type: Interventional
• Intervention(s): FOLFIRI/Ramucirumab treatment will be repeated with 2 weeks as a cycle.

Outcome(s)

• Primary Outcome: 6 months PFS rate

Secondary Outcome

Progression-free survival (PFS), Overall survival (OS),
Safety, Objective response rate (ORR), Early tumor shrinkage (ETS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Patients with histologically confirmed colorectal cancer
(2)Patients with RAS wild-type (KRAS exon 2 [codon12,13], exon 3 [codon59,61], exon 4 [codon117,146]; NRAS exon 2 [codon12,13], exon 3 [codon59, 61], exon 4 [codon117,146]), unresectable advanced/recurrent colorectal cancer
(3)Patients aged >= 20 years at the time of informed consent
(4)Patients with ECOG Performance Status (PS) 0 to 1
(5)Patients who have received any of 1) to 3) for the treatment of unresectable primary lesion site and unresectable distant metastasis or lymph node metastasis
1)Patients who have received 5-FU plus oxaliplatin plus an anti-EGFR antibody as a first-line therapy and have become refractory or intolerant to the therapy
2)Patients in whom the regimen needs to be changed because early tumor shrinkage (ETS) by >= 20% has not been obtained at efficacy assessment at Week 8 after the start of a first-line therapy with 5-FU plus oxaliplatin plus an anti-EGFR antibody
3)Patients who have received a combination with FOLFOXIRI plus an anti-EGFR antibody drug as a first-line therapy and have become refractory or intolerant during the subsequent maintenance therapy (with 5-FU plus levofolinate plus an anti-EGFR antibody drug)

Exclude criteria

(1)Patients with synchronous multiple primary cancers or with metachronous multiple primary cancers with disease interval of <= 5 years
(2)Patients with brain metastasis
(3)Patients with infection
(4)Patients with interstitial pneumonia or pulmonary fibrosis
(5)Patients with a serious cardiac disease or patients with a history of a serious cardiac disease within 12 months before enrollment
(6)Patients with any of the following previous or concomitant diseases associated with hemorrhage:
1)Intractable hemorrhage
2)Active hematemesis/hemoptysis
3)Gastrointestinal hemorrhage of >= Grade 3 within 3 months before enrollment
(7)Patients with any of the following previous or concomitant diseases associated with thromboembolism
1)Intractable thromboembolism
2)Any thrombosis, including deep vein thrombosis and pulmonary embolism, within 3 months before enrollment
(8)Patients with any cerebrovascular disorder
(9)Patients with poorly controlled hypertension
(10)Patients with cancerous body cavity fluid (such as pleural effusion, ascites, and cardiac effusion) requiring puncture and/or administration of diuretics
(11)Patients with any serious concurrent disease (such as renal failure and hepatic failure)
(12)Male patients with no will to take contraceptive measures, pregnant patients, breastfeeding patients, female patients with a positive result on pregnancy test, or female patients with no will to take contraceptive measures
(13)Patients with a past history of severe hypersensitivity
(14)Patients with a positive result for HBs antigen or HCV antigen
(15)Patients with hepatic cirrhosis of Child-Pugh class B or severer, or patients with hepatic encephalopathy regardless of the degree of the hepatic cirrhosis
(16)Patients who have received blood transfusion, blood products, or hematopoietic factor preparations such as G-CSF within 7 days before enrollment
(17)Patients who have received surgery, biopsy with incision, or suture for injury within 28 days before enrollment, or patients who have received central venous port placement or minor surgery within 7 days before enrollment
(18)Patients who need to be treated or are under treatment with drugs that inhibit platelet function (aspirin of >= 325 mg once daily or non-steroidal anti-inflammatory drugs [NSAIDs]) for the treatment of chronic inflammatory diseases such as rheumatoid arthritis
(19)Patients receiving antiplatelet therapy with drugs, including aspirin, dipyridamole, clopidogrel, and NSAIDs (excluding aspirin of <= 325 mg once daily)
(20)Patients with bleeding tendency (including hemoptysis, and hollowing or necrosis of lung metastasis on images), coagulation disorder, or abnormal coagulation factor
(21)Patients with active peptic ulcer
(22)Patients with gastrointestinal perforation or fistula, or patients with a history of gastrointestinal perforation or fistula within 6 months before enrollment
(23)Patients with unhealed traumatic fracture
(24)Patients with watery stools or uncontrolled diarrhea
(25)Patients with a history of organ transplantation requiring immunosuppressants
(26)Patients who have previously received ramucirumab
(27)Patients receiving atazanavir sulfate (Rayataz)
(28)Patients with intestinal paralysis or intestinal obstruction

Related Information

• Primary Sponsor: TSUJI Akihito
• Source(s) of Monetary Support: Eli Lilly Japan K.K.
• Secondary ID(s): Nil known