Multi-Center Prospective Randomized Trial Comparing Standard Esophagectomy Against Chemo-Radiotherapy for Treatment of Squamous Esophageal Cancer – Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)

Esophageal Cancer Clinical Trial

Official title:

Phase 3 Multicenter Randomized Study Comparing Esophagectomy Against Definitive Chemoradiation for Treatment of Squamous Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165061
• Other study ID #: CRE-9362
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: July 2000

Study information

• Verified date: September 2005
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

A multicenter randomized comparison of primary esophagectomy against definitive chemoradiotherapy for the treatment of squamous esophageal cancer.

Description:

Cancer of the oesophagus is notorious for its grave prognosis with an overall 5-year survival rate of 10-20%. Surgical resection with curative intent remains the most effective treatment for this disease. To improve the survival, a better treatment approach is in need to manage patients with oesophageal cancer. Unfortunately, the use of preoperative adjuvant chemotherapy or adjuvant radiotherapy does not confer any survival benefit to patients with localized oesophageal cancer as proven in most randomized studies. However, the combination of chemotherapy and radiotherapy has greater clinical efficacy in achieving complete pathological regression of the tumour as well as the response rate as shown in our preliminary results. In fact, treatment of squamous oesophageal cancer by primary chemo-irradiation without surgery is now feasible.

We propose to conduct a multi-center randomized trial to evaluate the efficacy and the patients’ survival by comparing primary chemo-irradiation without surgery versus standard surgical resection as the treatment for squamous oesophageal cancer. Those patients with residual cancer after primary chemo-irradiation will have salvage oesophagectomy to control the disease. Over a 3-year period, a total of 80 patients will be recruited from 4 different hospitals with 100 patients being randomized into each treatment arm. Treatment outcomes will be compared on an intention-to-treat analysis basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable

Exclusion Criteria:

• distant metastasis to solid visceral organs

• local invasion into trachea, descending aorta or recurrent laryngeal nerve.

• patients > 75 years

• serious premorbid condition

• poor physical status that compromised a thoracotomy

• compromised cardiac function

• creatinine clearance less than 50 ml/min were not eligible.

Study Design

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• Esophagectomy

• Chemoradiation

Locations

Country	Name	City	State
China	Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	1.Disease free survival
Secondary	2.Hospital stay
Secondary	3.Morbidities
Secondary	4.Recurrence of the disease