Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer (CELAEC)

Henan University of Science and Technology

Status: Enrolling

Conditions: Esophagus Cancer

Treatments: Procedure: CRT; Procedure: surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02972372

CRTESC6111

Details and patient eligibility

About

The aim of this study is to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT) by the randomized, open-label, multicenter trial.

Full description

Background: More than half of global esophageal cancer cases came from China, but the report about definitive chemoradiation (CRT) compared with esophagectomy in Chinese patients with locally advanced resectable esophageal squamous cell cancer (ESCC) is limited.

Aim: to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT).

Methods: 176 ESCC patients with T1bN+M0, T2-4aN0-2M0 will be randomized to CRT group or Surgery group.In the CRT group, patients will be given intensity modulation radiation therapy (IMRT) with 50Gy/25 fractions , and current chemotherapy with 5-fluorouracil (5-FU) basic regimens. In the surgery group, patients will received standard esophagectomy. 5 years follow-up for both groups patients.

Primary endpoints: 2 year and 5 year Disease free survival, Overall survival Second endpoints: treatment-related adverse events; the quality of life

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese
• esophageal squamous cell cancer
• mid or lower esophageal cancer
• tumor is resectable disease
• clinical stage: cT1bN+Mo, or cT2-4aN0-2M0

Exclusion criteria

• who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.
• who had a serious premorbid condition or a poor physical status that compromised a thoracotomy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

CRT group

Active Comparator group

Description:

3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in IMRT mode (total of 50Gy given in 25 fractions) will be given over a period 5-6 weeks.

Treatment:

Procedure: CRT

Surgery group

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: surgery