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

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ClinicalTrials.gov Identifier: NCT00544362
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

October 13, 2007
October 16, 2007
May 30, 2016
July 2007
January 2011   (Final data collection date for primary outcome measure)
  • Complete histologic response [ Time Frame: After Surgery ]
  • Tolerance to neoadjuvant therapy [ Time Frame: From Inclusion ]
  • Complete histologic response
  • Tolerance to neoadjuvant therapy
  • Toxicity
Complete list of historical versions of study NCT00544362 on ClinicalTrials.gov Archive Site
  • Progression-free and overall survival [ Time Frame: From inclusion ]
  • Mortality [ Time Frame: From Inclusion ]
  • Progression-free and overall survival
  • Complete resection with negative margins (R0)
  • Mortality
Not Provided
Not Provided
 
Fluorouracil, Cisplatin, Cetuximab, and Radiation Therapy in Treating Patients With Esophageal Cancer That Can Be Removed by Surgery
Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study

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.

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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Esophageal Cancer
  • Biological: cetuximab
  • Drug: cisplatin
  • Drug: fluorouracil
  • Procedure: conventional surgery
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
Interventions:
  • Biological: cetuximab
  • Drug: cisplatin
  • Drug: fluorouracil
  • Procedure: conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
45
March 2013
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00544362
CDR0000564075
FFCD-0505
EU-20756
EUDRACT-2006-004770-27
MERCK-FFCD-0505
No
Not Provided
Not Provided
Federation Francophone de Cancerologie Digestive
Federation Francophone de Cancerologie Digestive
Not Provided
Study Chair: Martina Schneider Federation Francophone de Cancerologie Digestive
Federation Francophone de Cancerologie Digestive
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP