Study rindo

JRCT ID: jRCTs041180074

Registered date:11/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: unresectable colorectal cancer
• Date of first enrollment: 29/01/2018
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Administration of low dose irinotecan

Outcome(s)

• Primary Outcome: progression-free survival (PFS)
• 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
• 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
• Source(s) of Monetary Support: Eli Lilly Japan K.K.