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Radiation Therapy and Chemotherapy, With or Without Cetuximab, Followed by Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

NCT01107639 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2020-10-20

No results posted yet for this study

Summary

RATIONALE: Radiation therapy uses high-energy x-rays and to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. It is not yet known whether giving radiation therapy together with chemotherapy is more effective with or without cetuximab in treating patients with esophageal cancer.

PURPOSE: This randomized phase III trial is studying giving radiation therapy together with chemotherapy, with or without cetuximab, followed by surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.

Conditions

  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Cancer

Interventions

BIOLOGICAL

cetuximab

Loading dose 400 mg/m2 2h infusion Weekly: 250 mg/m2 1h infusion

DRUG

cisplatin

* Cisplatin 75 mg/m2 1h infusion d1, 22 * Cisplatin 25 mg/m2 1h infusion weekly x5

DRUG

docetaxel

* Docetaxel 75 mg/m2 1h infusion d1, 22 * Docetaxel 20 mg/m2 1/2h infusion weekly x5

PROCEDURE

adjuvant therapy

During the adjuvant phase, all infusions, given every two weeks, will be at a dose of 500mg/m².

PROCEDURE

neoadjuvant therapy

During the neoadjuvant phase, the first infusion of cetuximab should be at a dose of 400 mg/m² administered over a period of 2 hours and all subsequent infusions, given weekly, should be of 250 mg/m² over a period of 1 hour, unless any infusion related reaction was observed at a previous infusion. (The maximum infusion rate is 10 mg/min, corresponding to 2 mL/min ready-to-use solution.

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Thomas Ruhstaller, MD · Cantonal Hospital of St. Gallen

  • Michael Stahl, MD · Kliniken Essen-Mitte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2010-05-27
Primary Completion
2016-10-06
Completion
2018-12-09

Countries

  • Austria
  • France
  • Germany
  • Hungary
  • Switzerland

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 NCT01107639 on ClinicalTrials.gov