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Clinical Trials/JPRN-UMIN000023026
JPRN-UMIN000023026
Completed
Phase 2

Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer - Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer

Department of Clinical Oncology, St. Marianna University School of Medicine0 sites54 target enrollmentAugust 1, 2016

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Colorectal cancer
Sponsor
Department of Clinical Oncology, St. Marianna University School of Medicine
Enrollment
54
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2016
End Date
December 21, 2018
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Department of Clinical Oncology, St. Marianna University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\) Previous treatment with irinotecan, bevacizumab, cetuximab/panitumumab 2\) Symptomatic brain metastasis 3\) Intestinal paralysis/obstruction 4\) Massive pleural effusion, ascites, or pericardial effusion 5\) Uncontrolled diarrhea 6\) Active synchronous or metachronous malignancy 7\) Severe infectious disease 8\) Grade2 or higher skin toxicity 9\) Interstitial pneumonia or pulmonary fibrosis 10\) Serious complication(uncontrolled diabetes, severe cardiac disease, renal failure, liver failure) 11\) History of thromboembolism 12\) Unhealed wounds 13\) Previous treatment with radiotherapy for primary disease 14\) Administration of aspirin 15\) Carcinomatous meningitis, uncontrolled epilepsy, mental disorder 16\) Systemic administration of steroid 17\) History of severe allergy 18\) Positive for HBs antigen 19\) Women who are pregnant or patients who are unwilling to avoid pregnancy 20\) Patients who are inappropriate for the study in the opinion of the investigator

Outcomes

Primary Outcomes

Not specified

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