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Trial record 21 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

Metronomic Versus Conventional Chemotherapy in as Maintenance Treatment in mCRC

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ClinicalTrials.gov Identifier: NCT02893540
Recruitment Status : Unknown
Verified September 2016 by Hao Li, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : September 8, 2016
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Hao Li, Ruijin Hospital

Brief Summary:
The optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer (mCRC) is unknown. This study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy versus conventional chemotherapy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Capecitabine Phase 2 Phase 3

Detailed Description:

In this Prospective, open-label, randomised controlled trial, the investigators will recruit 250 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. Then, the patients will be randomised into two group. The experimental group, capecitabine metronomic chemotherapy versus capecitabine conventional chemotherapy as control group. These treatment regimens will be continued until progression, death, or an unacceptable adverse event.

The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival (OS), quality of life (QOL) and toxic effects.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Capecitabine Metronomic Chemotherapy Versus Conventional Chemotherapy as Maintenance Treatment in Metastatic Colorectal Cancer
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metronomic
accept capecitabine metronomic chemotherapy (500mg, twice per day, everyday)
Drug: Capecitabine
we are going to compare two maintenance treatment models with capecitabine in this study
Other Name: Xeloda

Active Comparator: Conventional
accept capecitabine conventional chemotherapy (1000mg/m2, twice per day for 14 days, every 21 days)
Drug: Capecitabine
we are going to compare two maintenance treatment models with capecitabine in this study
Other Name: Xeloda




Primary Outcome Measures :
  1. PFS1 [ Time Frame: 4 months ]
    from randomizing to progression


Secondary Outcome Measures :
  1. OS [ Time Frame: 20 months ]
    from signing informed consent form to death

  2. QOL [ Time Frame: 20 months ]
    QLQ-C30



Information from the National Library of Medicine

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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:

  • Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained);
  • Distant metastases (patients with only local recurrence are not eligible);
  • Unidimensionally measurable disease (> 1 cm on spiral CT scan or > 2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation;
  • In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field.

Exclusion Criteria:

  • Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment;
  • Any prior adjuvant treatment after resection of distant metastases;
  • Previous systemic treatment for advanced disease.

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): NCT02893540


Contacts
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Contact: HAO LI, MD,Ph.D 86-15000929050 drlihao@163.com
Contact: JUN ZHANG, MD,Ph.D 86-18917762326 junzhang@188.com

Locations
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China, Shanghai
Shanghai Rui Jin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Yifeng Wang    8621-64370045 ext 665879    wyfkjc@163.com   
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Yifeng Wang, MD Shanghai Rui Jin Hospital

Publications:
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Responsible Party: Hao Li, MD, Ph.D, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02893540     History of Changes
Other Study ID Numbers: RJH-Oncol-Metronomic
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents