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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165061
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
Information provided by:
Chinese University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: Esophagectomy Procedure: Chemoradiation Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Phase 3 Multicenter Randomized Study Comparing Esophagectomy Against Definitive Chemoradiation for Treatment of Squamous Esophageal Cancer
Study Start Date : July 2000

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. 1.Disease free survival
  2. 2.Hospital stay
  3. 3.Morbidities
  4. 4.Recurrence of the disease

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165061

Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Philip WY Chiu, MBChB, FRCSEd Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Study Director: Angus CW Chan, MD Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong Identifier: NCT00165061     History of Changes
Other Study ID Numbers: CRE-9362
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 14, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases