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Clinical Trials/JPRN-UMIN000018484
JPRN-UMIN000018484
Recruiting
Phase 2

A phase II study to evaluate the effectiveness of S-1 + Cetuximab for patients with advanced/recurrent colon cancer who cannot undergo intensive therapy - S-1 and Cetuximab Colon Cancer trial ( SACC trial )

HO HOKKAIDO CANCER CENTER Division of Gastroenterology0 sites57 target enrollmentAugust 1, 2015

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
advanced/recurrent colon cancer patients with RAS wild-type tumors who cannot undergo intensive therapy
Sponsor
HO HOKKAIDO CANCER CENTER Division of Gastroenterology
Enrollment
57
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2015
End Date
November 30, 2017
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
HO HOKKAIDO CANCER CENTER Division of Gastroenterology

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\) History of severe allergy 2\) Active synchronous or metachronous malignancy 3\) Severe infectious disease 4\) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice) 5\) Massive pleural effusion or ascites 6\) Wattery diarrhea 7\) Prior treatment of cetuximab or L\-OHP or TS\-1 8\) Patients who is receiving Flucytosine 9\) Symptomatic brain metastasis 10\) Pregnant or lactating women or women of childbearing potential 11\) Severe mental disorders 12\) Systemic administration of steroid 13\) Severe renal failure, or urinary protein (more than 2\+). 14\) Prior radiotherapy for primary and metastases leision. 15\) History of allergy for L\-OHP and other platinating agent 16\) Sensory alteration or paresthesia interfering with function. 17\) Any other cases who are regarded as inadequate for study enrollment by the investigator.

Outcomes

Primary Outcomes

Not specified

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