JRCT ID: jRCTs041180074
Registered date:11/03/2019
Study rindo
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | unresectable colorectal cancer |
Date of first enrollment | 29/01/2018 |
Target sample size | 60 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Administration of low dose irinotecan |
Outcome(s)
Primary Outcome | progression-free survival (PFS) |
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Secondary Outcome | Overall survival (OS), time to treatment failure (TTF), objective response rate (ORR), early tumor shrinkage (ETS), depth of response (DpR), two-dimensional response (2-DR), relative dose intensity (RDI) of irinotecan and ramucirumab, and incidence of adverse events |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 80age old |
Gender | Both |
Include criteria | 1. Histologically confirmed colorectal adenocarcinoma. 2. Unresectable metastatic disease. 3. Age 20 to 80 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Prior oxaliplatin-based chemotherapy. 6. Prior bevacizumab or anti-EGFR containing regimen. 7. Bidimensionally measurable disease. 8. Adequate organ function. 9. The RAS mutation status (wild-type, mutant or not definable) of the patients is known prior to randomization. 10. Written informed consent was obtained. |
Exclude criteria | 1. Previous history of severe drug-induced allergy 2. Brain metastasis 3. Cerebrovascular disease or its symptoms within 1 year. 4. Massive pleural effusion or ascites that required drainage. 5. History of active double cancer. 6. Previous history of thoromboembolitic disease, or necessity for antithrombotic drug. 7. Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. 8. History of gastrointestinal perforation within 1 year. 9. Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy. 10. Severe renal failure or urinary protein (more than 2+). 11. Uncontrolled severe complications (DM, hypertension, diarrhea, et al.). 12. Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated. 13. Interstitial lung disease or pulmonary fibrosis. 14. Uncontrolled infection. 15. Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week. 16. UGT1A1 gene status of homo type (*28/*28, *6/*6) or double hetero-type genetic polymorphisms *28 or *6 (*1/*28 and *1/*6). 17. Prior irinotecan or ramucirumab containing chemotherapy 18. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 19. Not appropriate for the study at the physician's assessment. |
Related Information
Primary Sponsor | Nakayama Goro |
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Secondary Sponsor | |
Source(s) of Monetary Support | Eli Lilly Japan K.K. |
Secondary ID(s) |
Contact
Public contact | |
Name | Miyuki Aoki |
Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan Aichi Japan 466-8550 |
Telephone | +81-52-744-2249 |
miyuki.a@med.nagoya-u.ac.jp | |
Affiliation | Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine |
Scientific contact | |
Name | Goro Nakayama |
Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan Aichi Japan 466-8550 |
Telephone | +81-52-744-2249 |
goro@med.nagoya-u.ac.jp | |
Affiliation | Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine |