Possibilities for Improvement of an Outcome of the Treatment in Squamous Cell Carcinoma of the Thoracic Esophagus - a Multicenter Randomized Clinical Phase III Trial.
18 Years
75 Years
Both
Esophageal Neoplasms, Squamous Cell Cancer
Trial Information
Possibilities for Improvement of an Outcome of the Treatment in Squamous Cell Carcinoma of the Thoracic Esophagus - a Multicenter Randomized Clinical Phase III Trial.
The choice of the most beneficial method of treatment in esophageal cancer remains
controversial and is the subject of vigorous debate. Surgery is still regarded as the
principle modality among treatment strategies, with longterm survival achieved mainly in
less advanced cases. More advanced cases, diagnosed more frequently, are more problematic in
selection of the optimal therapeutic method. One of the options for improving treatment
outcome in patients with advanced esophageal cancer is combined modality treatment with
chemo- and chemoradiotherapy. Currently available RCTs have tested preoperative chemotherapy
or chemoradiotherapy separately in comparison to surgery alone. Moreover, we do not know
from these trials what is the added value of irradiation in a combined modality therapy over
a preoperative chemotherapy. Another drawback of available RCTs is combining 2 different
biological cancer entities: adenocarcinoma and squamous cell carcinoma of the esophagus as
well as carcinoma of the esophagus and gastro-esophageal junction. That were the reasons for
designing our trial testing 3 principal modes of esophageal cancer therapy: surgery vs.
chemotherapy + surgery vs. chemoradiotherapy + surgery on homogenous population of
esophageal cancer patients with single pathological type - squamous cell carcinoma affecting
thoracic esophagus.
Inclusion Criteria:
- Informed consent
- Histopathologically proven, clinically stage II-III (cTNM according to AJCC/UICC
classification), primary squamous cell carcinoma of the thoracic esophagus
- Patients' age above 18 years
- General condition with Karnofsky performance status of >70
- Circulatory and pulmonary capacity at normal range (FEV1 >60%; FVC >60%, NYHA I-II,
cardiac output >40%)
- Normal function of the bone marrow (RBC >3,5 T/l; PLT >100 G/l)
- Normal renal (creatinine <1.5 of the upper limit) and liver (AST or ALT <2,5 of the
upper limit or bilirubin <1,5 of the upper limit) function
Exclusion Criteria:
- Metastatic disease
- Synchronous malignancy
- History of other cancer within 5 years prior to esophageal cancer treatment
- History of allergic reaction to cisplatin of 5-fluorouracil
- Systemic infection
- Pregnancy or female patients in childbearing age without proper contraceptives.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
mean, median, 1-year, 3-year, 5-year overall survival
Outcome Time Frame:
5 years
Principal Investigator
Grzegorz Wallner, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland
Authority:
Poland: Ministry of Science and Higher Education
Study ID:
6P05C01320
NCT ID:
NCT00559351
Start Date:
December 2001
Completion Date:
April 2004
Related Keywords:
- Esophageal Neoplasms
- Squamous Cell Cancer
- esophagectomy
- chemotherapy
- chemoradiotherapy
- combined modality therapy
- Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Esophageal Diseases
- Esophageal Neoplasms
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