Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study
18 Years
75 Years
Both
Esophageal Cancer
Trial Information
Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete histologic response
Safety Issue:
No
Principal Investigator
Martina Schneider
Investigator Role:
Study Chair
Investigator Affiliation:
Federation Francophone de Cancerologie Digestive
Authority:
Unspecified
Study ID:
CDR0000564075
NCT ID:
NCT00544362
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
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