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Completed

NCT Number: NCT03564912

Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in CRC

This study select the diagnosis of postoperative colorectal cancer patients with stage II/III to adjuvant chemotherapy, and received 2 weeks and 3 weeks xelox adjuvant treatment process until disease progression or patients died or lost to follow-up. To analyze the difference in efficacy and safety of xelox in 2 weeks and 3 weeks of postoperative adjuvant therapy for colorectal cancer, so as to find a better postoperative adjuvant treatment model.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

First afflicated hospital of zhejiang university

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Carcinoma of the intestine confirmed histologically or cytologically
  • Radical surgical resection was performed after diagnosis and the post operative stages were high-risk II or III patients
  • The ECOG PS score less than or equal to 2 points
  • No chemotherapy of any kind has been performed in the past
  • Neutrophils acuity 1.5x10e9/L, platelets more than 100x10e9/L, college blood red protein more than 9g/dL
  • liver function transaminase is less than or equal to 2.5 ULN, alkaline phosphatase is less than 2.5 ULN, and total bilirubin is less than 1.5 ULN

Exclusion criteria

  • Patients with unresectable CRC
  • Patients who have any form of chemotherapy before
  • Participating in or having participated in clinical studies of other drug
  • Patients have second primary malignant tumors of have other malignant tumors in the past five years
  • There is evidence of allergic reaction to drugs in this study
  • A history of ischemic heart disease in the past 1 year or patients with high risk factors for heart failure, or uncontrolled arrhythmias
  • Severe active inflammation, including tuberculosis and HIV
  • Long-term immunization or hormone therapy, except hormone replacement therapy at physiological dose
  • Drug or alcohol addiction
  • Get pregnant or breastfeed
  • The investigator considers that the patient is not suitable for this clinical study due to any clinical or laboratory abnormalities or compliance problems

Treatment and study plan

Capecitabine Oral Tablet [Xeloda]

Drug

2 week group: capecitabine 1000mg/m2 d1-10; oxaliplatin 85mg/m2; q2w 3 week group: capecitabine 1000mg/m2 d1-14; oxaliplatin 130mg/m2; q3w

Other names: oxaliplatin

Primary outcomes

  1. DFS

    Time frame: through study completion, an average of 1 year

    disease free survival

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 2 weeks

    toxicity difference of two groups

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in Colorectal Patients After Surgery

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2018
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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