RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus

Esophageal Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00559351
• Other study ID #: 6P05C01320
• Secondary ID: PL SCSR 6P05C013
• Status: Terminated
• Phase: Phase 3
• First received: November 15, 2007
• Last updated: November 15, 2007
• Start date: December 2001
• Est. completion date: April 2004

Study information

• Verified date: September 2007
• Source: Ministry of Scientific Research and Information Technology, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Neoplasms, Squamous Cell
• Squamous Cell Cancer

Intervention

Procedure:
• transthoracic esophagectomy 2-field extended lymphadenectomy
right thoracotomy, mobilization of the esophagus, mediastinal lymph node dissection, laparotomy, gastric tube formation, abdominal lymph node dissection, anastomosis in the neck

Drug:
• neoadjuvant chemotherapy (cisplatin, 5-fluorouracil)
21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval

Radiation:
• neoadjuvant chemoradiotherapy
21-day combination systemic chemotherapy regimen consisted of a continuous infusion of cisplatin (20mg/m2/day) on days 1-5, 17-21 and 5-fluorouracil at 300mg/m2/day on days 1-21 with concurrent external beam fractionated irradiation to a total dose of 30Gy (2Gy fractions on days 1-5, 8-12, 15-19) followed by 3-phase transthoracic esophagectomy with 2-field extended lymphadenectomy after 3 week interval

Locations

Country	Name	City	State
Poland	2nd Department of General, Gastrointestinal Surgery & Surgical Oncology of the Digestive Tract, Medical University of Lublin, Poland	Lublin	Lubelskie

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Scientific Research and Information Technology, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean, median, 1-year, 3-year, 5-year overall survival		5 years
Secondary	toxicity-related morbidity and mortality		30-day
Secondary	postoperative morbidity and mortality		30-day
Secondary	clinical and pathological response rates		60-day
Secondary	curative resection rate		30-day