CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 344 enrolled
Drug / intervention
cetuximab +3 moredrug
Likely dose
cetuximab 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00655876
NCT00655876Phase 3Completed

A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery

Radiation Therapy Oncology Group·interventional·Posted Apr 10, 2008·Updated Jun 14, 2022

In Brief

A Phase 3 clinical trial evaluating cetuximab, cisplatin, and 2 other interventions for Esophageal Cancer. Completed, enrolled 344 participants across 175 sites in 2 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer. PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 10, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2015
Study CompletionMay 20, 2022
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 18.2 years ago

Interventions

cetuximabdrug

Weekly with external beam radiation therapy for a total of six doses. The initial dose of cetuximab is 400 mg/m\^2 intravenously administered over 120 minutes on day 1, followed by weekly infusions of 250 mg/m\^2 intravenously over 60 minutes on days 8, 15, 22, 29, and 36. The infusion rate of cetuximab must never exceed 5 mL/min.

cisplatindrug

Weekly with external beam radiation therapy for a total of six doses. Patients receive 25 mg/m\^2 as an intravenous infusion over 30-60 minutes on days 1, 8, 15, 22, 29 and 36.

paclitaxeldrug

Weekly with external beam radiation therapy for a total of six doses. Patients receive 50 mg/m\^2 as an intravenous infusion over 1 hour on days 1, 8, 15, 22, 29 and 36.

radiation therapyradiation

1.8 Gy daily for 28 days (over 5-6 weeks) for a total dose of 50.4 Gy.