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

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: capecitabine plus oxaliplatin

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Department of Colorectal Surgery Fudan University Shanghai Caner Center
      • Contact: Ye Xu, M.D; Phone Number: +86-21-6417-5590; Email: xu_shirley021@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neoadjuvant chemotherapy; A total of 55 cases of locally advanced colon cancer will be enrolled in this arm. After radiological staging, patients were treated first with 3 cycles of neoadjuvant chemotherapy consisting of oxaliplatin, 130 mg/m² on day 1, with capecitabine, 1000 mg/m² twice daily for 14 days every 3 weeks (the XELOX regimen), followed by tumor resection, and then with another 5 cycles of adjuvant chemotherapy with the XELOX regimen. Radiological response was evaluated after 2 cycles of neoadjuvant chemotherapy . A total of 3 cycles neoadjuvant chemotherapy was completed unless there was unacceptable toxicity, emergency operation condition or tumor progression during the period. Tumor responses, toxicities, and surgical complications were recorded. The pathological tumor response in the primary tumor was evaluated according to tumor regression grade (TRG) score.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The tumor regression grade of all the patients enrolled	from the first cycle of treatment (day one) to tumor resection

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants receiving complete tumor resection	From date of randomization until the date of the last patients receiving the surgery
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

Collaborators and Investigators

• Sponsor: Fudan University

Publications and helpful links

General Publications

• Liu F, Yang L, Wu Y, Li C, Zhao J, Keranmu A, Zheng H, Huang D, Wang L, Tong T, Xu J, Zhu J, Cai S, Xu Y. CapOX as neoadjuvant chemotherapy for locally advanced operable colon cancer patients: a prospective single-arm phase II trial. Chin J Cancer Res. 2016 Dec;28(6):589-597. doi: 10.21147/j.issn.1000-9604.2016.06.05.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 9, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Neoajuvant chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Oxaliplatin
• Other Study ID Numbers: 1501143-1