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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)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01032967
Enrollment
40
Registered
2009-12-16
Start date
2000-07-31
Completion date
2009-06-30
Last updated
2009-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancers

Keywords

squamous cell carcinoma, esophagectomy, chemoradiotherapy, chemoradiation, Squamous cell carcinomas of the esophagus

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).

Interventions

PROCEDUREEsophagectomy

The patients will receive standard open esophagectomy with two-field lymphadenectomy

RADIATIONDefinitive 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.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Overall survival and disease-free survival2 year and 5 year

Secondary

MeasureTime frame
Quality of life and function outcomes2 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026