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

Primary Purpose

Colorectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

capecitabine plus oxaliplatin

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Neoajuvant chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Department of Colorectal Surgery Fudan University Shanghai Caner CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant chemotherapy

Arm 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.

Outcomes

Primary Outcome Measures

The tumor regression grade of all the patients enrolled

Secondary Outcome Measures

Number of Participants receiving complete tumor resection

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Full Information

NCT ID

NCT02415829

First Posted

March 30, 2015

Last Updated

April 9, 2015

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02415829

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Neoajuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

capecitabine plus oxaliplatin

Intervention Description

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)

Primary Outcome Measure Information:

Title

The tumor regression grade of all the patients enrolled

Time Frame

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

Secondary Outcome Measure Information:

Title

Number of Participants receiving complete tumor resection

Time Frame

From date of randomization until the date of the last patients receiving the surgery

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time Frame

from the first cycle of treatment (day one) to six month after the last cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Department of Colorectal Surgery Fudan University Shanghai Caner Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ye Xu, M.D

Phone

+86-21-6417-5590

xu_shirley021@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

28174487

Citation

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.

Results Reference

derived

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

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