Surgery or Chemoradiation for Esophageal Cancer

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status and phase

Completed
Phase 3

Conditions

Esophageal Cancers

Treatments

Procedure: Esophagectomy
Radiation: Definitive chemoradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT01032967
Surgery or CRT Ca Esophagus

Details and patient eligibility

About

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).

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Surgery, esophagectomy
Active Comparator group
Description:
The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
Treatment:
Procedure: Esophagectomy
Definitive chemoradiation
Active Comparator group
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.
Treatment:
Radiation: Definitive chemoradiation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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