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Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer

NCT02071069 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-11-18

No results posted yet for this study

Summary

1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer.
2. The relevant phase III studies reported that the progression free-survival of cetuximab combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months.

This study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy

Conditions

  • Incurable Colorectal Cancer
  • RAS-wild-type

Interventions

DRUG

Cetuximab

400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks

DRUG

irinotecan

180 mg/m2 IV every 2 weeks

DRUG

fluorouracil

400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks

Sponsors & Collaborators

  • Tianshu Liu

    lead OTHER

Principal Investigators

  • Tianshu Liu, Doctor · Medicine-Oncology Derpartment of Zhongshan hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-05-31
Completion
2016-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02071069 on ClinicalTrials.gov