Efficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer Patients

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02415829
• Other study ID #: 1501143-1
• Status: Recruiting
• Phase: Phase 2
• First received: March 30, 2015
• Last updated: April 9, 2015
• Start date: November 2014

Study information

• Verified date: April 2015
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Fudan University Shanghai Cancer Center China
• Study type: Interventional

Clinical Trial Summary

The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with local advanced colorectal cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Performance status (ECOG) 0~2

2. Histologically confirmed colon cancer.

3. No prior treatment

4. CT-defined T4 or lymph node-positive colon cancer

5. Neutrophils = 1.5 x 109/L, platelets = 100 x 109/L, and hemoglobin = 8 g/dL Bilirubin level = 1.0 x ULN

6. AST and ALT < 1.5 x ULN

7. Serum creatinine = 1.0 x ULN

8. Life expectancy of = 3 months

9. Signed written informed consent

Exclusion Criteria:

1. Final stage with cancer cachexia

2. Allergy for capecitabine or oxaliplatin

3. Any evidence of extrahepatic metastases and/or primary tumor recurrence

4. Severe organ failures or diseases, including: clinically relevant coronary disease, cardiovascular disorder or myocardial infarction within 12 months before study entry, severe psychiatric illness, severe infection and DIC

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Drug:
• capecitabine plus oxaliplatin
The neoadjuvant chemotherapy consisted of oxaliplatin, 130 mg/m² on day 1, with capecitabine, 1000 mg/m² twice daily for 14 days every 3 weeks (the XELOX regimen)

Locations

Country	Name	City	State
China	Department of Colorectal Surgery Fudan University Shanghai Caner Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The tumor regression grade of all the patients enrolled		from the first cycle of treatment (day one) to tumor resection	No
Secondary	Number of Participants receiving complete tumor resection		From date of randomization until the date of the last patients receiving the surgery	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		from the first cycle of treatment (day one) to six month after the last cycle	Yes