NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041180074

Registered date:11/03/2019

Study rindo

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedunresectable colorectal cancer
Date of first enrollment29/01/2018
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)Administration of low dose irinotecan

Outcome(s)

Primary Outcomeprogression-free survival (PFS)
Secondary OutcomeOverall 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
Age maximum<= 80age old
GenderBoth
Include criteria1. 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 criteria1. 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

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
E-mail 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
E-mail goro@med.nagoya-u.ac.jp
Affiliation Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine