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Trial record 84 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

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

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ClinicalTrials.gov Identifier: NCT03564912
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Weijia Fang, MD, Zhejiang University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Capecitabine Oral Tablet [Xeloda] Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in Colorectal Patients After Surgery
Actual Study Start Date : August 12, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2 week group Drug: Capecitabine Oral Tablet [Xeloda]
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 Name: oxaliplatin

Active Comparator: 3 week group Drug: Capecitabine Oral Tablet [Xeloda]
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 Name: oxaliplatin




Primary Outcome Measures :
  1. DFS [ Time Frame: through study completion, an average of 1 year ]
    disease free survival


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 weeks ]
    toxicity difference of two groups



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03564912


Contacts
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Contact: FANG M WEIJIA, doctor +86 13758211655 ext 87236858 weijiafang@zju.edi.cn
Contact: ZHANG F hangyu, master +86 15757747033 ext 87236858 zhanghangyu@pku.edu.cn

Locations
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China, Zhejiang
First afflicated hospital of zhejiang university Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: fang M weijia, doctor         
Sponsors and Collaborators
Zhejiang University

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Responsible Party: Weijia Fang, MD, director, Zhejiang University
ClinicalTrials.gov Identifier: NCT03564912     History of Changes
Other Study ID Numbers: ZhejiangU020
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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