Suspended
Efficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer Patients
What is being tested
capecitabine plus oxaliplatin
Drug
Who is being recruted
Colonic Diseases+8
+ Digestive System Diseases
+ Digestive System Neoplasms
From 18 to 75 Years
+13 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: November 2014
Summary
Principal SponsorFudan University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2014
Actual date on which the first participant was enrolled.The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with local advanced colorectal cancer.
Official TitleEfficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer Patients
Principal SponsorFudan University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
55 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms
Criteria
9 inclusion criteria required to participate
Performance status (ECOG) 0~2
Histologically confirmed colon cancer.
No prior treatment
CT-defined T4 or lymph node-positive colon cancer
Show More Criteria
4 exclusion criteria prevent from participating
Final stage with cancer cachexia
Allergy for capecitabine or oxaliplatin
Any evidence of extrahepatic metastases and/or primary tumor recurrence
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
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalA 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Department of Colorectal Surgery Fudan University Shanghai Caner Center
Shanghai, ChinaOpen Department of Colorectal Surgery Fudan University Shanghai Caner Center in Google MapsSuspendedOne Study Center