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Cetuximab Maintenance Treatment Versus Continuation After Induction Therapy in mCRC

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02942706
Recruitment Status : Not yet recruiting
First Posted : October 24, 2016
Last Update Posted : April 30, 2021
Sponsor:
Collaborators:
Chinese PLA General Hospital
Xiangya Hospital of Central South University
West China Hospital
Tongji Hospital
Information provided by (Responsible Party):
Jun Zhang, Ruijin Hospital

Brief Summary:
This study is try to evaluate the effect of cetuximab monotherapy as maintenance treatment, versus continuation after 8 courses of induction therapy with cetuximab plus standard chemotherapy regimen (FOLFIRI or mFOLFOX6)in metastatic colorectal cancer (mCRC) patients. The maintenance treatments are continued until disease progression or untolerated toxicity. The aim of this study is to demonstrate that cetuximab monotherapy is non-inferior to continuation treatment, in those mCRC patients who responded to induction therapy(SD, PR, or CR), and carry biomarker-panels (KRAS, NRAS, BRAF, and PIK3CA) favor EGFR antibody.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Cetuximab Drug: mFOLFOX6 Drug: FOLFIRI Phase 2 Phase 3

Detailed Description:
This study is try to evaluate the effect of cetuximab monotherapy as maintenance treatment, versus continuation after 8 courses of induction therapy with cetuximab plus standard chemotherapy regimen (FOLFIRI or mFOLFOX6)in metastatic colorectal cancer (mCRC) patients. The maintenance treatments are continued until disease progression or untolerated toxicity. The aim of this study is to demonstrate that cetuximab monotherapy is non-inferior to continuation treatment, in those mCRC patients who responded to induction therapy(SD, PR, or CR), and carry biomarker-panels (KRAS, NRAS, BRAF, and PIK3CA) favor EGFR antibody. Furthermore, the mutation status of biomarker panel consist of KRAS, NRAS, HRAS, BRAF, EGFR, ERBB2, ERBB3, PIK3CA, PTEN, SMAD4, SMAD2, TGFBR2, cMET, Src, mTOR, VEGFR1, VEGFR2, EPHA2, MSI, TP53, ERCC1, ERCC5, KCNQ5, ILK, and Myc will be analyzed by NGS sequencing. The ctDNA as surrogate marker via liquid biopsy will be conducted before randomization, during maintenance treatment, and disease progression.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarker-Panel Guided Maintenance Treatment With Cetuximab Monotherapy Versus Continuation After First Line Induction Therapy of Metastatic Colorectal Cancer (mCRC) : a Multicenter, Prospective, Randomized Controlled Trial
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Cet maintenance
Cetuximab maintenance treatment following induction treatment
Drug: Cetuximab
anti-EGFR monoclonal antibody
Other Name: Erbitux

Active Comparator: Cet+chemo continuation
Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens
Drug: Cetuximab
anti-EGFR monoclonal antibody
Other Name: Erbitux

Drug: mFOLFOX6
Oxaliplatin+LV5FU2

Drug: FOLFIRI
Irinotecan+LV5FU2




Primary Outcome Measures :
  1. Progression Free Survival 1 (PFS1) [ Time Frame: 4 months ]
    from randomization to progression


Secondary Outcome Measures :
  1. Progression Free Survival 2 (PFS2) [ Time Frame: 10 months ]
    from signing informed consent to progression

  2. Overall Survival (OS) [ Time Frame: 24 months ]
    from signing informed consent to death

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 24 months ]
    drug related toxicity from signing informed consent to death

  4. Quality of life (QoL) [ Time Frame: 24 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.


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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

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 either technically unresectable or no chance to reach NED (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;
  • Ongoing or planned first line induction therapy with 8 cycles of FOLFIRI or mFOLFOX6.

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
  • RAS mutant mCRC

At randomisation:

Inclusion criteria:

  • WHO performance status 0-1 (Karnofsky PS > 70%);
  • Disease evaluation with proven SD, PR or CR according to RECIST after 8 cycles of FOLFIRI or mFOLFOX6;
  • Laboratory values obtained ≤ 2 weeks prior to randomisation: adequate bone marrow function (Hb > 8.0 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 > 24 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): NCT02942706


Contacts
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Contact: Jun Zhang, MD & Ph. D +86-13818332497 junzhang10977@sjtu.edu.cn
Contact: Min Shi, MD & Ph. D +86-13512118830 shimin0412005@126.com

Sponsors and Collaborators
Ruijin Hospital
Chinese PLA General Hospital
Xiangya Hospital of Central South University
West China Hospital
Tongji Hospital
Investigators
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Principal Investigator: Jun Zhang, MD & Ph.D Ruijin Hospital
Publications:
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Responsible Party: Jun Zhang, MD & Ph. D, Professor of Oncology, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02942706    
Other Study ID Numbers: BLOC-1
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents