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.
Title
- Brief Title: Cetuximab Maintenance Treatment Versus Continuation After Induction Therapy in mCRC
- 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
Clinical Trial IDs
- ORG STUDY ID:
BLOC-1
- NCT ID:
NCT02942706
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Cetuximab | Erbitux | Cet maintenance |
mFOLFOX6 | | Cet+chemo continuation |
FOLFIRI | | Cet+chemo continuation |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Cet maintenance | Experimental | Cetuximab maintenance treatment following induction treatment | |
Cet+chemo continuation | Active Comparator | Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens | |
Eligibility 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;
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival 1 (PFS1) |
Time Frame: | 4 months |
Safety Issue: | |
Description: | from randomization to progression |
Secondary Outcome Measures
Measure: | Progression Free Survival 2 (PFS2) |
Time Frame: | 10 months |
Safety Issue: | |
Description: | from signing informed consent to progression |
Measure: | Overall Survival (OS) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | from signing informed consent to death |
Measure: | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Time Frame: | 24 months |
Safety Issue: | |
Description: | drug related toxicity from signing informed consent to death |
Measure: | Quality of life (QoL) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | QoL from signing informed consent to death |
Details
Phase: | Phase 2/Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Ruijin Hospital |
Last Updated
April 30, 2021