search
Back to results

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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
cetuximab
cisplatin
fluorouracil
conventional surgery
Sponsored by
Federation Francophone de Cancerologie Digestive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

  • Prior anticancer chemotherapy or radiotherapy
  • Treatment with endoprosthesis
  • Surgery (esophagectomy) planned without thoracotomy

Sites / Locations

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
  • Hopital Saint Andre
  • C.H.U. de Brest
  • CHR Clermont Ferrand, Hotel Dieu
  • Hopital Du Bocage
  • Federation Francophone de Cancerologie Digestive
  • Centre Oscar Lambret
  • Centre Hospital Universitaire Hop Huriez
  • CHU de la Timone
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Regional de Purpan
  • Centre Alexis Vautrin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant chemoradiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Complete histologic response
Tolerance to neoadjuvant therapy

Secondary Outcome Measures

Progression-free and overall survival
Mortality

Full Information

First Posted
October 13, 2007
Last Updated
May 27, 2016
Sponsor
Federation Francophone de Cancerologie Digestive
search

1. Study Identification

Unique Protocol Identification Number
NCT00544362
Brief Title
Fluorouracil, Cisplatin, Cetuximab, and Radiation Therapy in Treating Patients With Esophageal Cancer That Can Be Removed by Surgery
Official Title
Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Primary 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) Secondary 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant chemoradiotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
cetuximab
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Primary Outcome Measure Information:
Title
Complete histologic response
Time Frame
After Surgery
Title
Tolerance to neoadjuvant therapy
Time Frame
From Inclusion
Secondary Outcome Measure Information:
Title
Progression-free and overall survival
Time Frame
From inclusion
Title
Mortality
Time Frame
From Inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: 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 PRIOR CONCURRENT THERAPY: Exclusion criteria: Prior anticancer chemotherapy or radiotherapy Treatment with endoprosthesis Surgery (esophagectomy) planned without thoracotomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martina Schneider
Organizational Affiliation
Federation Francophone de Cancerologie Digestive
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
C.H.U. de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHR Clermont Ferrand, Hotel Dieu
City
Clermont-Ferrand
ZIP/Postal Code
63058
Country
France
Facility Name
Hopital Du Bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Federation Francophone de Cancerologie Digestive
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Hospital Universitaire Hop Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Regional de Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs