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Trial record 15 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02575378
Recruitment Status : Unknown
Verified October 2015 by Hao Li, Ruijin Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 14, 2015
Last Update Posted : October 14, 2015
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 plus Chinese Traditional Medicine.

In this Prospective, open-label, randomised controlled trial, the investigators will recruit 159 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. The patients will then accept Chinese traditional diagnosis and be randomised into two group, capecitabine metronomic chemotherapy only as control group and the metronomic chemotherapy plus Chinese Traditional Medicine as experimental group. This treatment regimen 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.


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Metronimic chemotherapy plus Chinese Traditional Medicine Drug: Metronimic chemotherapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Metronomic chemotherapy
Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
Drug: Metronimic chemotherapy
Capecitabine 300mg/m2, twice a day, everyday

Experimental: Metronimic chemotherapy plus Chinese Traditional Medicine

Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.

Chinese Traditional Medicine

Drug: Metronimic chemotherapy plus Chinese Traditional Medicine
Capecitabine 300mg/m2, twice a day, everyday plus Chinese Traditional Medicine




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: six months ]
    from randomising to progression, death, unacceptable AE



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:

  1. unresectable metastatic colorectal cancer with pathological confirmation.
  2. patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR.

Exclusion Criteria:

-


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Responsible Party: Hao Li, associate chief physician, Department of Oncology, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02575378     History of Changes
Other Study ID Numbers: ZHYY-ZYYZX-rjzl
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Hao Li, Ruijin Hospital:
Metastatic Colorectal Cancer
Maintenance Treatment
Chinese Traditional Medicine
Clinical Trial
efficacy
safety
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