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Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study



- 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


- 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

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.

Inclusion Criteria


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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete histologic response

Safety Issue:


Principal Investigator

Martina Schneider

Investigator Role:

Study Chair

Investigator Affiliation:

Federation Francophone de Cancerologie Digestive



Study ID:




Start Date:

July 2007

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • 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
  • Esophageal Diseases
  • Esophageal Neoplasms