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)

NCT00165061 | Completed Phase 3

• 1 other identifier: CRE-9362
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (4)

• 1.Disease free survival

• 2.Hospital stay

• 3.Morbidities

• 4.Recurrence of the disease

Interventions

Esophagectomy PROCEDURE

Chemoradiation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Esophagectomy; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Philip WY Chiu, MBChB, FRCSEd

  Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Angus CW Chan, MD

  Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 14, 2005
• Study Start: July 1, 2000
• Last Updated: September 14, 2005

Record last verified: 2005-09

Locations

CN (1)