Clinical trial NCT02284529: Safety of Orectalip® (Oxaliplatin) as Adjuvant Treatment for High-risk Stage-Ⅱ Colorectal Cancer
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stage-Ⅱ Colorectal Cancer
Keywords: high-risk stage-Ⅱ Colorectal Cancer,Orectalip,oxaliplatin
Lead sponsor: Sinphar Pharmaceutical Co., Ltd
Sponsor class: OTHER
Collaborators: name: Taichung Veterans General Hospital
First posted: 2014-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia) in the end of study
timeFrame: 6month
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: vghtc.crs@gmail.com
name: Hwei-Ming Wang, Chief
role: PRINCIPAL_INVESTIGATOR
References: