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Clinical Trials/JPRN-jRCTs041180166
JPRN-jRCTs041180166
Active, not recruiting
Phase 2

Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer (WJOG9216G) - WJOG9216G, RECAST

Kito Yosuke0 sites120 target enrollmentMarch 29, 2019
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Kito Yosuke
Enrollment
120
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 29, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kito Yosuke

Eligibility Criteria

Inclusion Criteria

  • •1\) Histologically or cytologically diagnosed adenocarcinoma of the colon or rectum (excluding the appendix and anal canal).
  • •2\) Tumor is clinically determined to be unresectable for a radical cure.
  • •3\) Age of 20\-75 years.
  • •4\) ECOG PS of 0\-1 (a PS 0 is required for subjects aged 71\-75 years).
  • •5\) Measurable lesion according to RECIST, version 1\.1\.
  • •6\) No history of chemotherapy (however, subjects may register if they have received adjuvant chemotherapy with fluoropyrimidine monotherapy and the cancer recurrence occurred \> 24 weeks after the last dose. Patients who have received OX\-based adjuvant chemotherapy may not register.)
  • •7\. Retained organ function.
  • •8\. UGT1A1 gene status of wild type (\*1/\*1\), or \*28, \*6 genetic polymorphism single hetero\-type (\*1/\*28, \*1/\*6\).
  • •9\. The RAS mutation status (wild\-type, mutant or not definable) of the patients is known prior to randomization.

Exclusion Criteria

  • •1\) Serious complications.
  • •2\) Receipt of a blood transfusion or hematopoietic factor therapy within 2 weeks prior to registration.
  • •3\) Grade 2 or worse peripheral sensory neuropathy.
  • •4\) History of Grade 3 or worse thromboembolism within 6 months before the scheduled treatment start date.
  • •5\) Receiving anti\-platelet agents. Aspirin use at doses up to 325 mg/day is permitted.
  • •6\) Women who are pregnant, breastfeeding, had a positive pregnancy test, or women and men who do not wish to use contraception.

Outcomes

Primary Outcomes

Not specified

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