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

NCT02415829 | Unknown Phase 2

• 1 other identifier: 1501143-1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Keywords

Neoajuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• The tumor regression grade of all the patients enrolled

  from the first cycle of treatment (day one) to tumor resection

Secondary Outcomes (2)

• 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

Study Arms (1)

Neoadjuvant chemotherapy

EXPERIMENTAL

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

Interventions

capecitabine plus oxaliplatin DRUG

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)

Neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Performance status (ECOG) 0\~2
• Histologically confirmed colon cancer.
• No prior treatment
• CT-defined T4 or lymph node-positive colon cancer
• Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL Bilirubin level ≤ 1.0 x ULN
• AST and ALT \< 1.5 x ULN
• Serum creatinine ≤ 1.0 x ULN
• Life expectancy of ≥ 3 months
• Signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Colorectal Surgery Fudan University Shanghai Caner Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 28174487 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 14, 2015
• Study Start: November 1, 2014
• Primary Completion: January 1, 2016
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

CN (1)