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Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma

NCT03126708 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-01-04

No results posted yet for this study

Summary

This is an open-label, randomized, controlled trial. At the end of a 28-day screening period, all eligible subjects will be randomly assigned into treatment Arm A or B in a 1:1 ratio. Subjects in Arm A will receive a maximum of 6 cycles of chemotherapy (cisplatin plus paclitaxel) and cetuximab weekly in the absence of progressive disease (PD), as assessed by the Investigator, and unacceptable toxicity. After 6 cycles of treatment, subjects who derive clinical benefit will continue treatment with cetuximab as monotherapy until either PD or unacceptable toxicity. Subjects in Arm B will receive the same chemotherapy regimen as Arm A alone for a maximum of 6 cycles in the absence of PD and unacceptable toxicity.

Conditions

  • Esophageal Cancer, Squamous Cell
  • Cetuximab Effect
  • Chemotherapy Effect

Interventions

DRUG

cetuximab

cetuximab (EGFR monoclonal antibody) plus standard chemotherapy

DRUG

cisplatin plus paclitaxel

Chemotherapy

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Lin Shen, MD · Peking Universtiy Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2019-04-30
Completion
2020-04-30

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 NCT03126708 on ClinicalTrials.gov