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

NCT ID: NCT02284529

Last Updated: 2014-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-09-30

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.

Conditions

Stage-Ⅱ Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Orectalip® (Oxaliplatin)

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

Group Type: EXPERIMENTAL

Orectalip

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Fluorouracil; Leucovorin

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taichung Veterans General Hospital

OTHER

Sponsor Role: collaborator

Sinphar Pharmaceutical Co., Ltd

OTHER

Sponsor Role: lead

Responsible Party

Douglas Shr-Wei Chen

Taichung Veterans General Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hwei-Ming Wang, Chief

Role: PRINCIPAL_INVESTIGATOR

vghtc.crs@gmail.com

Locations

Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

SF12099

Identifier Type: -

Identifier Source: org_study_id