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| ID | Type | Description | Link |
|---|---|---|---|
| FFCD-0505 | |||
| EU-20756 | |||
| EUDRACT-2006-004770-27 | |||
| MERCK-FFCD-0505 |
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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
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemoradiotherapy | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab | Biological |
| ||
| cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Complete histologic response | After Surgery | |
| Tolerance to neoadjuvant therapy | From Inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free and overall survival | From inclusion | |
| Mortality | From Inclusion |
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DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically confirmed epidermoid or glandular carcinoma of the thoracic esophagus
Resectable disease
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martina Schneider | Federation Francophone de Cancerologie Digestive | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Besançon | 25030 | France | |||
| Hopital Saint Andre |
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|
| fluorouracil | Drug |
|
| conventional surgery | Procedure |
|
| Bordeaux |
| 33075 |
| France |
| C.H.U. de Brest | Brest | 29200 | France |
| CHR Clermont Ferrand, Hotel Dieu | Clermont-Ferrand | 63058 | France |
| Hopital Du Bocage | Dijon | 21034 | France |
| Federation Francophone de Cancerologie Digestive | Dijon | 21079 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Hospital Universitaire Hop Huriez | Lille | 59037 | France |
| CHU de la Timone | Marseille | 13385 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Centre Hospitalier Regional de Purpan | Toulouse | 31059 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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