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Cetuximab Monotherapy Maintenance Treatment in mCRC

Biomarker-Panel Enriched Maintenance Treatment With Cetuximab Monotherapy Versus Continuation After Induction Treatment With Chemotherapy + Cetuximab in Metastatic Colorectal Cancer (mCRC)

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02978313
Enrollment
500
Registered
2016-11-30
Start date
2016-11-30
Completion date
2019-11-30
Last updated
2016-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

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.

Interventions

DRUGCetuximab

anti-EGFR monoclonal antibody

DRUGmFOLFOX6

Oxaliplatin+LV5FU2

DRUGFOLFIRI

Irinotecan+LV5FU2

Sponsors

Jiangsu Cancer Institute & Hospital
CollaboratorOTHER
Henan Cancer Hospital
CollaboratorOTHER_GOV
Second Affiliated Hospital, School of Medicine, Zhejiang University
CollaboratorOTHER
Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frame
PFS4-6 months

Secondary

MeasureTime frame
OS22 months
QoL22 months

Contacts

Primary ContactJun Zhang, PhD
junzhang@188.com+-86-18917762326

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026