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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: capecitabine plus oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02415829

1501143-1

Details and patient eligibility

About

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

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Neoadjuvant chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: capecitabine plus oxaliplatin