Surgery or Chemoradiation for Esophageal Cancer

The Chinese University of Hong Kong

Status and phase: Completed; Phase 3

Conditions: Esophageal Cancers

Treatments: Radiation: Definitive chemoradiation; Procedure: Esophagectomy

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)

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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