NCT02942706

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_2 colorectal-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
5 years until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

October 2, 2016

Last Update Submit

April 29, 2021

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival 1 (PFS1)

    from randomization to progression

    4 months

Secondary Outcomes (4)

  • Progression Free Survival 2 (PFS2)

    10 months

  • Overall Survival (OS)

    24 months

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    24 months

  • Quality of life (QoL)

    24 months

Study Arms (2)

Cet maintenance

EXPERIMENTAL

Cetuximab maintenance treatment following induction treatment

Drug: Cetuximab

Cet+chemo continuation

ACTIVE COMPARATOR

Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens

Drug: CetuximabDrug: mFOLFOX6Drug: FOLFIRI

Interventions

CetuximabDRUG

anti-EGFR monoclonal antibody

Also known as: Erbitux
Cet maintenanceCet+chemo continuation
mFOLFOX6DRUG

Oxaliplatin+LV5FU2

Cet+chemo continuation
FOLFIRIDRUG

Irinotecan+LV5FU2

Cet+chemo continuation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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;
  • Chronic active infection;
  • Any other concurrent severe or uncontrolled disease preventing the safe administration of study drugs;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Wasan H, Meade AM, Adams R, Wilson R, Pugh C, Fisher D, Sydes B, Madi A, Sizer B, Lowdell C, Middleton G, Butler R, Kaplan R, Maughan T; COIN-B investigators. Intermittent chemotherapy plus either intermittent or continuous cetuximab for first-line treatment of patients with KRAS wild-type advanced colorectal cancer (COIN-B): a randomised phase 2 trial. Lancet Oncol. 2014 May;15(6):631-9. doi: 10.1016/S1470-2045(14)70106-8. Epub 2014 Apr 3.

    PMID: 24703531BACKGROUND

  • Tveit KM, Guren T, Glimelius B, Pfeiffer P, Sorbye H, Pyrhonen S, Sigurdsson F, Kure E, Ikdahl T, Skovlund E, Fokstuen T, Hansen F, Hofsli E, Birkemeyer E, Johnsson A, Starkhammar H, Yilmaz MK, Keldsen N, Erdal AB, Dajani O, Dahl O, Christoffersen T. Phase III trial of cetuximab with continuous or intermittent fluorouracil, leucovorin, and oxaliplatin (Nordic FLOX) versus FLOX alone in first-line treatment of metastatic colorectal cancer: the NORDIC-VII study. J Clin Oncol. 2012 May 20;30(15):1755-62. doi: 10.1200/JCO.2011.38.0915. Epub 2012 Apr 2.

    PMID: 22473155BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

CetuximabIFL protocol

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jun Zhang, MD & Ph.D

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhang, MD & Ph. D

CONTACT

+86-13818332497junzhang10977@sjtu.edu.cn

Min Shi, MD & Ph. D

CONTACT

+86-13512118830shimin0412005@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD & Ph. D, Professor of Oncology

Study Record Dates

First Submitted

October 2, 2016

First Posted

October 24, 2016

Study Start

November 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share