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NCT Number: NCT02972372

Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer

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.

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Key information

Conditions

Esophagus Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anyang Tumor Hospital, Anyang, Henan, China

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRT

Procedure

Drug: Capecitabine(Aibin) capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total

Other Names:

Aibin Drug: Oxaliplatin(Aiheng) Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.

Other Names:

Aiheng cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85. 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88.

Radiation: Radiotherapy concurrent radiotherapy：IMRT radiotherapy 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

Other names: concurrent chemoradiotherapy

Surgery

Procedure

The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy

Other names: esophagectomy

Primary outcomes

  1. 2-year disease-free survival rate

    Time frame: 2 year

    The percent of 2 year disease-free survival after random allocation, percent

Secondary outcomes

  1. Treatment-related adverse events

    Time frame: 2 year

    The percent of treatment-related adverse events after 2 year random allocation, percent

  2. QoF (quality of life)

    Time frame: 2 year

    The quality of life evaluation after 2 year of random allocation by questionnaire, 1-10 score, 1 means poor and 10 means best

  3. 2 year overall survival

    Time frame: 2 year

    The percent of 2 year overall survival after random allocation, percent

Study contacts

Contact information is provided by the study sponsor or research team.

Ruinuo Jia, MD

CONTACT

[email protected]

+86 18537950766

Shegan Gao, MD, PhD

CONTACT

[email protected]

+86 18638859977

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Other

Collaborators

  • 150th Hospital of PLA
  • Anyang Tumor Hospital
  • Jiangsu HengRui Medicine Co., Ltd.

Registry information

Official study title

A Randomized, Open-label, Multicenter Trial of the Chemoradiation Versus Standard Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Cancer in Chinese Patients

Acronym: CELAEC

Important dates

Study start
2016
Primary completion
2025
Study completion
2027
First posted
Nov 23, 2016
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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