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Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

NCT00655876 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2022-06-14

Study results available
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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.

Conditions

  • Esophageal Cancer

Interventions

DRUG

cetuximab

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.

DRUG

cisplatin

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.

DRUG

paclitaxel

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

radiation therapy

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    collaborator OTHER

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Mohan Suntharalingam, MD · University of Maryland Greenebaum Cancer Center

  • David H. Ilson, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2015-04-30
Completion
2022-05-20

Countries

  • United States
  • Canada

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 NCT00655876 on ClinicalTrials.gov