Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158610
Recruitment Status : Enrolling by invitation
First Posted : May 18, 2017
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Jun Zhang, Ruijin Hospital

Brief Summary:
Based upon biological behavior, those mCRC patients who respond well (SD, PR or CR according to RECIST Criteria) after 16-18 weeks of standard doublet chemotherapy as induction may enrolled into this study, randomly divided into capecitabine metronomic group or standard dosage group. The duration of disease control after randomization(PFS2) and progression free survival from enrollment (PFS1) are primary endpoints. Meanwhile, the overall survival, safety and quality of life are secondary endpoints. Exploratory markers involving angiogenesis (serum VEGF, PDGF, Tie-1 and Tie2, etc) and immune function (CD clusters, serum tumor mutation burden(TMB), etc), are conducted via liquid biopsy.

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

Detailed Description:
This study is try to evaluate the effect of capecitabine metronomic chemotherapy as maintenance treatment, which compare to capecitabine conventional chemotherapy, who have responded to 16-18 months first-line chemotherapy in metastatic colorectal cancer (mCRC). The maintenance treatments are continued until disease progression or severe toxicity. The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy. Furthermore, exploratory markers involving angiogenesis (serum VEGF, PDGF, Tie-1 and Tie2, etc) and immune function (CD clusters, serum tumor mutation burden(TMB), etc), are conducted via liquid biopsy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Responders After Induction Therapy in Metastatic Colorectal Cancer
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : January 29, 2021
Estimated Study Completion Date : January 29, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Capecitabine metronomic chemotherapy
Capecitabine 500mg/m2 bid po qd
Drug: Capecitabine
Oral fluorouracil
Other Name: Xeloda

Active Comparator: Capecitabine standard dosage chemotherapy
Capecitabine 1000mg/m2 bid po d1-d14,q3w
Drug: Capecitabine
Oral fluorouracil
Other Name: Xeloda




Primary Outcome Measures :
  1. Progression Free Survival 1 (PFS1) [ Time Frame: 10 months ]
    from enrollment to progression

  2. Progression Free Survival 2 (PFS2) [ Time Frame: 4 months ]
    from randomization to progression


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 20 months ]
    from signing informed consent to death

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 20 months ]
    drug related toxicity from signing informed consent to death

  3. Number of participants with quality of life (QoL) as assessed by CTCAE v4.0 [ Time Frame: 20 months ]
    QoL from signing informed consent to death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Before the start of induction therapy:

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 which are unresectable (patients with only local recurrence are not eligible);
  • 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;

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

At randomisation:

Inclusion criteria:

  • WHO performance status 0-1 (Karnofsky PS > 70%);
  • Disease evaluation with proven SD, PR or CR according to RECIST after first-line induction treatment;
  • Laboratory values obtained ≤ 2 weeks prior to randomisation: adequate bone marrow function (Hb > 6.0 mmol/L, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L), renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, > 30 ml/min), liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases);
  • Life expectancy > 12 weeks;
  • Age: 18-75 years;
  • Negative pregnancy test in women with childbearing potential;
  • Expected adequacy of follow-up;
  • Institutional Review Board approval;
  • Written informed consent Exclusion criteria
  • Chronic active infection;
  • Any other concurrent severe or uncontrolled disease preventing the safe administration of study drugs;

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): NCT03158610


Locations
Layout table for location information
China
Department of Oncology, Ruijin Hospital
Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jun Zhang, MD & Ph. D Ruijin Hospital

Publications:

Layout table for additonal information
Responsible Party: Jun Zhang, Deputy-chief of Department of Oncology, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03158610     History of Changes
Other Study ID Numbers: BIG-MOON
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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