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

Primary Purpose

Stage-Ⅱ Colorectal Cancer

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Orectalip
Sponsored by
Sinphar Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage-Ⅱ Colorectal Cancer focused on measuring high-risk stage-Ⅱ Colorectal Cancer,Orectalip,oxaliplatin

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Subject must have World Health Organization performance status score less than 1.
  2. Subject must have WBC more than 4,000 cells, platelet count more than 100,000, absolute neutrophil count more than 1,500 serum bilirubin level less than1.5mg, serum creatinine level less than1.5mg

Exclusion Criteria

  1. Subject who has received oxaliplatin treatment
  2. Subject who has history of allergy to platinum derivates agents
  3. Subject who has decompensated liver function(ALT、 AST and alkaline phosphatase more than 2.5 times of upper limit of normal range).
  4. Subject has serious concomitant illness preceding the entry into the study.
  5. Female subject who is pregnant or breast feeding.
  6. Female subject who is going to be pregnant within 6 months during treatment.

Sites / Locations

  • Taichung Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orectalip® (Oxaliplatin)

Arm Description

High-risk Stage-Ⅱ Colorectal Cancer treatment with 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 to execute 8~12 cycles

Outcomes

Primary Outcome Measures

To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia) in the end of study
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(cycle/ 2 weeks)To execute 12 cycles

Secondary Outcome Measures

Full Information

First Posted
October 23, 2014
Last Updated
November 3, 2014
Sponsor
Sinphar Pharmaceutical Co., Ltd
Collaborators
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02284529
Brief Title
Safety of Orectalip® (Oxaliplatin) as Adjuvant Treatment for High-risk Stage-Ⅱ Colorectal Cancer
Acronym
Oxaliplatin
Official Title
Evaluate the Safety of Combination of Orectalip® (Oxaliplatin), Fluorouracil and Leucovorin as Adjuvant Treatment for High-risk Stage-Ⅱ Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sinphar Pharmaceutical Co., Ltd
Collaborators
Taichung Veterans General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
There were 18 out of 20 patients who completed the trial and eligible for statistical analysis, 2 patients withdraw because the wound infection. There were 11 (61%) male patients and 7 (39%) female patients. The patients aged from 30 to 73 years and their mean age was 50.4 years. The grade of each adverse event evaluation mainly allocated in Grade 0 and Grade 1. The incidence of Grade 3 or 4 was only found for the following symptoms: leucopenia, neutropenia, and anemia. One (6%) adverse event of leucopenia occurred at visit 1 and visit 2, respectively. One (6%) adverse event of neutropenia occurs at visit 1, visit 2, and visit 3, respectively; while 2 (13%) events occurred at visit 5. One patients suffered adverse event of anemia at visit 5 and visit 6.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage-Ⅱ Colorectal Cancer
Keywords
high-risk stage-Ⅱ Colorectal Cancer,Orectalip,oxaliplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orectalip® (Oxaliplatin)
Arm Type
Experimental
Arm Description
High-risk Stage-Ⅱ Colorectal Cancer treatment with 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 to execute 8~12 cycles
Intervention Type
Drug
Intervention Name(s)
Orectalip
Other Intervention Name(s)
Fluorouracil, Leucovorin
Intervention Description
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
Primary Outcome Measure Information:
Title
To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia) in the end of study
Description
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(cycle/ 2 weeks)To execute 12 cycles
Time Frame
6month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subject must have World Health Organization performance status score less than 1. Subject must have WBC more than 4,000 cells, platelet count more than 100,000, absolute neutrophil count more than 1,500 serum bilirubin level less than1.5mg, serum creatinine level less than1.5mg Exclusion Criteria Subject who has received oxaliplatin treatment Subject who has history of allergy to platinum derivates agents Subject who has decompensated liver function(ALT、 AST and alkaline phosphatase more than 2.5 times of upper limit of normal range). Subject has serious concomitant illness preceding the entry into the study. Female subject who is pregnant or breast feeding. Female subject who is going to be pregnant within 6 months during treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hwei-Ming Wang, Chief
Organizational Affiliation
vghtc.crs@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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