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Safety of Orectalip® (Oxaliplatin) as Adjuvant Treatment for High-risk Stage-Ⅱ Colorectal Cancer

NCT02284529 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-11-06

No results posted yet for this study

Summary

Open- Label, Single Arm Study. To evaluate the safety profile of Orectalip® (oxaliplatin), fluorouracil and leucovorin as adjuvant therapy in the treatment of high-risk stage-Ⅱ colorectal cancer.

Primary end point:To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia) in the end of study.

Other end points:The incidence of Grade 3 or 4 neutropenia, thrombocytopenia, anemia, nausea, diarrhea vomiting over the 12 weeks.

Safety will be evaluated including vital signs are recorded at all visits.

Conditions

  • Stage-Ⅱ Colorectal Cancer

Interventions

DRUG

Orectalip

Oxaliplatin 85mg/m2 in D5W 250 ml IV drip 2hrs on D1, Leucovorin 100mg/m2 in N/S 100ml IV drip 2hrs on D1, follow by 5-FU 2400mg/m2 IV infusion 24hrs on D1

Sponsors & Collaborators

  • Taichung Veterans General Hospital

    collaborator OTHER

  • Sinphar Pharmaceutical Co., Ltd

    lead OTHER

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02284529 on ClinicalTrials.gov