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Surgery or Chemoradiation for Esophageal Cancer

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01032967
First received: December 15, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted

December 15, 2009
December 15, 2009
July 2000
June 2009   (final data collection date for primary outcome measure)
Overall survival and disease-free survival [ Time Frame: 2 year and 5 year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Quality of life and function outcomes [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Surgery or Chemoradiation for Esophageal Cancer
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)

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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancers
  • 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.
  • Active Comparator: Surgery, esophagectomy
    The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
    Intervention: Procedure: Esophagectomy
  • Active Comparator: 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.
    Intervention: Radiation: Definitive chemoradiation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01032967
Surgery or CRT Ca Esophagus
Yes
Professor Philip Chiu, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Philip W Chiu, FRCSEd (Gen) Chinese University of Hong Kong
Chinese University of Hong Kong
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP