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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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ClinicalTrials.gov Identifier: NCT02415829
Recruitment Status : Unknown
Verified April 2015 by Ye Xu, Fudan University.
Recruitment status was:  Recruiting
First Posted : April 14, 2015
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Ye Xu, Fudan University

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: capecitabine plus oxaliplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. The tumor regression grade of all the patients enrolled [ Time Frame: from the first cycle of treatment (day one) to tumor resection ]

Secondary Outcome Measures :
  1. Number of Participants receiving complete tumor resection [ Time Frame: From date of randomization until the date of the last patients receiving the surgery ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415829


Locations
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China, Shanghai
Department of Colorectal Surgery Fudan University Shanghai Caner Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ye Xu, M.D    +86-21-6417-5590    xu_shirley021@163.com   
Sponsors and Collaborators
Fudan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ye Xu, professor, Fudan University
ClinicalTrials.gov Identifier: NCT02415829     History of Changes
Other Study ID Numbers: 1501143-1
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by Ye Xu, Fudan University:
Neoajuvant chemotherapy

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents