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Fluorouracil, Cisplatin, Cetuximab, and Radiation Therapy in Treating Patients With Esophageal Cancer That Can Be Removed by Surgery

This study has been completed.
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive Identifier:
First received: October 13, 2007
Last updated: May 27, 2016
Last verified: May 2016

RATIONALE: Drugs used in chemotherapy, such as fluorouracil 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving fluorouracil and cisplatin together with cetuximab and radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and cisplatin when given together with cetuximab and radiation therapy in treating patients with esophageal cancer that can be removed by surgery.

Condition Intervention Phase
Esophageal Cancer
Biological: cetuximab
Drug: cisplatin
Drug: fluorouracil
Procedure: conventional surgery
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study

Resource links provided by NLM:

Further study details as provided by Federation Francophone de Cancerologie Digestive:

Primary Outcome Measures:
  • Complete histologic response [ Time Frame: After Surgery ] [ Designated as safety issue: No ]
  • Tolerance to neoadjuvant therapy [ Time Frame: From Inclusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free and overall survival [ Time Frame: From inclusion ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: From Inclusion ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: July 2007
Study Completion Date: March 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoadjuvant chemoradiotherapy
Weekly cetuximab (400 mg/m2 one week before start of radiotherapy RT and 250 mg/m2 during radiotherapyRT), and 5 FU (500 mg/m2 per day D1-D4) combined with cisplatin CDDP (40 mg/m2 D1) on week 1 and 5
Biological: cetuximab Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery

Detailed Description:



  • To determine the maximum tolerated dose of fluorouracil and cisplatin when administered with cetuximab concurrently with esophageal radiotherapy. (Phase I)
  • To determine the complete histological response rate (after surgical resection). (Phase II)


  • To determine progression-free survival and overall survival. (Phase II)
  • To determine the rate of resection with negative margins (R0). (Phase II)
  • To determine the overall tolerance to neoadjuvant therapy. (Phase II)
  • To determine the postoperative morbidity and mortality. (Phase II)

OUTLINE: This is a multicenter study. This is a dose-escalation study of cisplatin and fluorouracil.

Patients receive cetuximab IV over 2 hours on day -7, then IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also receive cisplatin IV over 1 hour on day 1 or 2 and fluorouracil IV continuously on days 1-4, 8-11, 15-18, 22-25, and 29-32. Patients undergo radiotherapy 5 days a week for 5 weeks, beginning on day 1 of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients undergo surgery within 6-8 weeks after completion of chemoradiotherapy.

After completion of study therapy, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 2 years.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


Inclusion criteria:

  • Histologically confirmed epidermoid or glandular carcinoma of the thoracic esophagus

    • Invasive disease
    • Only Siewert type I gastroesophageal carcinoma allowed
  • Resectable disease

    • T1N+, T2N0, T2N+, T3N0, or T3N+ (stage II or III)
    • No visceral metastases or mediastinal extensions compromising resectability

Exclusion criteria:

  • Inoperable disease
  • Invasion of the tracheo-bronchial tree
  • Recurring esophageal paralysis
  • Esopho-tracheal fistula
  • Cervical esophageal carcinoma (< 19 cm above the dental arches)
  • Multifocal esophageal carcinoma
  • Superficial esophageal carcinoma (T1N0)
  • Esophageal carcinoma in the lymph nodes that cannot be included in the radiotherapy field or cannot be completely surgically resected
  • Proven metastatic disease


Inclusion criteria:

  • WHO performance status 0-1
  • Weight loss < 15%
  • Absolute neutrophil count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Creatinine ≤ 1.25 times upper limit of normal
  • PTT ≥ 80%
  • Albumin ≥ 35 g/L
  • FEV1 > 1 L
  • Not pregnant or nursing
  • Fertile patients of must use effective contraception

Exclusion criteria:

  • Known liver cirrhosis
  • Renal insufficiency
  • Respiratory insufficiency (i.e., severe dyspnea at rest or oxygen dependence)
  • Progressive coronary insufficiency
  • Myocardial infarction in the past 6 months
  • Legally incapacitated
  • Impossible to receive study therapy due to geographical, social, or psychological reasons
  • Noncompliant within constraints of the study
  • Hematologic malignancy or other cancer except carcinoma in situ of the uterine cervix, treated nonmelanoma skin cancer, or intramucous disease treated within the past 3 years


Exclusion criteria:

  • Prior anticancer chemotherapy or radiotherapy
  • Treatment with endoprosthesis
  • Surgery (esophagectomy) planned without thoracotomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00544362

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Hopital Saint Andre
Bordeaux, France, 33075
C.H.U. de Brest
Brest, France, 29200
CHR Clermont Ferrand, Hotel Dieu
Clermont-Ferrand, France, 63058
Hopital Du Bocage
Dijon, France, 21034
Federation Francophone de Cancerologie Digestive
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59020
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
CHU de la Timone
Marseille, France, 13385
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Centre Hospitalier Regional de Purpan
Toulouse, France, 31059
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Study Chair: Martina Schneider Federation Francophone de Cancerologie Digestive
  More Information

Responsible Party: Federation Francophone de Cancerologie Digestive Identifier: NCT00544362     History of Changes
Other Study ID Numbers: CDR0000564075  FFCD-0505  EU-20756  EUDRACT-2006-004770-27  MERCK-FFCD-0505 
Study First Received: October 13, 2007
Last Updated: May 27, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Federation Francophone de Cancerologie Digestive:
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
stage IIIA esophageal cancer
stage IIIB esophageal cancer
stage IIIC esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on October 27, 2016