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Cetuximab Monotherapy Maintenance Treatment in mCRC

Sponsor
Ruijin Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02978313
Collaborator
Jiangsu Cancer Institute & Hospital (Other), Henan Cancer Hospital (Other), Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
500
Enrollment
2
Arms
36
Duration (Months)

Study Details

Study Description

Brief Summary

Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of progression.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of progression. This treatment is continued until progression or severe toxicity.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Biomarker-Panel Enriched Maintenance Treatment With Cetuximab Monotherapy Versus Continuation After Induction Treatment With Chemotherapy + Cetuximab in Metastatic Colorectal Cancer (mCRC)
Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cet maintenance

Cetuximab maintenance treatment following induction treatment

Drug: Cetuximab
anti-EGFR monoclonal antibody
Other Names:
  • erbitux

    		•
    Active Comparator: Cet+chemo continuation

    Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens

    Drug: Cetuximab
    anti-EGFR monoclonal antibody
    Other Names:
  • erbitux

    • Drug: mFOLFOX6
    Oxaliplatin+LV5FU2

    Drug: FOLFIRI
    Irinotecan+LV5FU2

    Outcome Measures

    Primary Outcome Measures

    1. PFS [4-6 months]

    Secondary Outcome Measures

    1. OS [22 months]

    2. QoL [22 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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;

    • Ongoing or planned first line treatment with 6 cycles of mFOLFOX6/FOLFIRI plus Cetuximab.

    At randomisation:

    • WHO performance status 0-1 (Karnofsky PS > 70%);

    • 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);

    • Negative pregnancy test in women with childbearing potential;

    • Expected adequacy of follow-up;

    • Institutional Review Board approval;

    • Written informed consent Exclusion criteria;

    • History or clinical signs/symptoms of CNS metastases;

    • History of a second malignancy ≤ 5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin.

    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ruijin Hospital
    • Jiangsu Cancer Institute & Hospital
    • Henan Cancer Hospital
    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    • Principal Investigator: Yifeng Wang, MD, Ruijin Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hao Li, MD &Ph.D, Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT02978313
    Other Study ID Numbers:
    • RJH-Cet-Maintenance
    First Posted:
    Nov 30, 2016
    Last Update Posted:
    Nov 30, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Cetuximab

    Study Results

    No Results Posted as of Nov 30, 2016