NCT00559351

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

Possibilities for Improvement of an Outcome of the Treatment in Squamous Cell Carcinoma of the Thoracic Esophagus - a Multicenter Randomized Clinical Phase III Trial.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Ministry of Scientific Research and Information Technology, Poland · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Neoplasms
• Squamous Cell Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2001-12-01
• Completion: 2004-04-01
• First posted: 2007-11-16
• Last updated: 2007-11-16

Locations

1 site across 1 country: Poland