Surgery or Chemoradiation for Esophageal Cancer
Primary Purpose
Esophageal Cancers
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Esophagectomy
Definitive chemoradiation
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancers focused on measuring squamous cell carcinoma, esophagectomy, chemoradiotherapy, chemoradiation, Squamous cell carcinomas of the esophagus
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Surgery, esophagectomy
Definitive chemoradiation
Arm Description
The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
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.
Outcomes
Primary Outcome Measures
Overall survival and disease-free survival
Secondary Outcome Measures
Quality of life and function outcomes
Full Information
NCT ID
NCT01032967
First Posted
December 15, 2009
Last Updated
December 15, 2009
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01032967
Brief Title
Surgery or Chemoradiation for Esophageal Cancer
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancers
Keywords
squamous cell carcinoma, esophagectomy, chemoradiotherapy, chemoradiation, Squamous cell carcinomas of the esophagus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery, esophagectomy
Arm Type
Active Comparator
Arm Description
The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
Arm Title
Definitive chemoradiation
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Esophagectomy
Intervention Description
The patients will receive standard open esophagectomy with two-field lymphadenectomy
Intervention Type
Radiation
Intervention Name(s)
Definitive chemoradiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival and disease-free survival
Time Frame
2 year and 5 year
Secondary Outcome Measure Information:
Title
Quality of life and function outcomes
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip W Chiu, FRCSEd (Gen)
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22887465
Citation
Teoh AY, Chiu PW, Yeung WK, Liu SY, Wong SK, Ng EK. Long-term survival outcomes after definitive chemoradiation versus surgery in patients with resectable squamous carcinoma of the esophagus: results from a randomized controlled trial. Ann Oncol. 2013 Jan;24(1):165-71. doi: 10.1093/annonc/mds206. Epub 2012 Aug 10.
Results Reference
derived
PubMed Identifier
21233603
Citation
Teoh AY, Yan Chiu PW, Wong TC, Liu SY, Hung Wong SK, Ng EK. Functional performance and quality of life in patients with squamous esophageal carcinoma receiving surgery or chemoradiation: results from a randomized trial. Ann Surg. 2011 Jan;253(1):1-5. doi: 10.1097/SLA.0b013e3181fcd991.
Results Reference
derived
Learn more about this trial
Surgery or Chemoradiation for Esophageal Cancer
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