Clinical trial NCT00559351: RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus
Official title: Possibilities for Improvement of an Outcome of the Treatment in Squamous Cell Carcinoma of the Thoracic Esophagus - a Multicenter Randomized Clinical Phase III Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Esophageal Neoplasms
Squamous Cell Cancer
Keywords: esophagectomy
chemotherapy
chemoradiotherapy
combined modality therapy
Lead sponsor: Ministry of Scientific Research and Information Technology, Poland
Sponsor class: OTHER_GOV
First posted: 2007-11-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant treatment of esophageal cancer.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: mean, median, 1-year, 3-year, 5-year overall survival
timeFrame: 5 years
Secondary outcomes:
measure: toxicity-related morbidity and mortality
timeFrame: 30-day
measure: postoperative morbidity and mortality
timeFrame: 30-day
measure: clinical and pathological response rates
timeFrame: 60-day
measure: curative resection rate
timeFrame: 30-day
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: 2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland
state: Lubelskie
Study officials:
affiliation: 2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland
name: Grzegorz Wallner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: