Surgery or Chemoradiation for Esophageal Cancer

Esophageal Cancers Clinical Trial

Official title:

Multicenter Prospective Randomized Trial Comparing Standard Esophagectomy With Chemoradiotherapy for Treatment of Squamous Esophageal Cancer: Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032967
• Other study ID #: Surgery or CRT Ca Esophagus
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2009
• Last updated: December 15, 2009
• Start date: July 2000
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Joint CUHK-NTEC Clinical Research Ethics Committee, Hong Kong:
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare outcomes in patients with operable squamous carcinoma of the esophagus who have received either surgery or definitive chemoradiation (CRT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• The investigators excluded those patients who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.

• Those patients who were older than 75 years or who had a serious premorbid condition or a poor physical status that compromised a thoracotomy were also excluded.

Study Design

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

Related Conditions & MeSH terms

• Esophageal Cancers
• Esophageal Neoplasms

Intervention

Procedure:
• Esophagectomy
The patients will receive standard open esophagectomy with two-field lymphadenectomy

Radiation:
• Definitive chemoradiation
3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival and disease-free survival		2 year and 5 year	Yes
Secondary	Quality of life and function outcomes		2 year	Yes