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NCT Number: NCT04135664

Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma

The ad-ESD trial is phase III randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage N0 and pathological stage T1b squamous cell carcinoma (after endoscopic submucosal dissection).

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Key information

Conditions

Esophageal 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

Phase 3

Primary location

The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China

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About this study

Esophagectomy is still the primary treatment for pathological T1b esophageal squamous cell carcinoma. However, esophagectomy is associated with high mortality and morbidity and decreased quality of life. Endoscopic resection followed with chemoradiation had showed uncompromised oncological outcomes with esophagectomy. But there is no well-designed, phase III trial to compare the two treatment for patients with pT1b squamous cell carcinoma.

The ad-ESD trial is a multi-center prospective superiority trial, combied of a randomized clinical trial and a prospective registry.

The experimental design produces two randomized arms; (1) esophagectomy and (2) chemoradiation. An additional registry arm will be based on surgeons/patients that do not want to be randomised because of their own experience on adjuvant therapy, including esophagectomy; chemoradiation and active surveillance.

The primary endpoint is to evaluate the difference of 5-year overall survival rate between definitive chemoradiation and esophagectomy, in patients with cN0-pT1b esophageal squamous cell cancer (ESCC) after endoscopic resection.

The secondary endpoints are to evaluate the difference of quality of life and oncological outcomes including 3-year overall survival (OS) and 3, 5-year relapse free survival (RFS) between the two treatments.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Biopsy proven with esophageal squamous cell cancer.
  • Clinical N0 stage diagnosed by imaging examinations.
  • Pathological T1b stage confirmed by endoscopic submucosal dissection.
  • Age: 18-75.
  • Tumor located at the thorax.
  • Performance status Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Written informed consent.

Exclusion criteria

  • Prior intervention treatment before endoscopic submucosal resection.
  • Inability to accept any treatment component.
  • Prior intervention (surgery, chemoradiation, et al.) for other primary tumor disease.
  • Distant metastasis.
  • The circumference of the lumen over 3/4
  • Main tumor size > 5cm assessed by endoscopy
  • Inability to understand the informed consent.

Treatment and study plan

Esophagectomy

Procedure

esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy

Chemoradiation

Combination Product

concurrent chemotherapy and radiotherapy

Active Surveillance

Other

No further adjuvant therapy

Primary outcomes

  1. 5-year overall survival rate

    Time frame: 5 years after enrollment day

    The overall survival is defined as days from date of randomization to death from any cause, and cencored at the last day of follow up when patients are alive.

Secondary outcomes

  1. 3-year overall survival rate

    Time frame: 3 years after enrollment day

    The overall survival is defined as days from date of randomization to death from any cause, and cencored at the last day of follow up when patients are alive.

  2. 3-year relapse free survival rate

    Time frame: 3 years after enrollment day

    The relapse free survival is defined as days from date of randomization until the date of tumor progression or the date of death causing of any reasons, and cencored at the last day of follow up when patients are alive.

  3. 5-year relapse free survival rate

    Time frame: 5 years after enrollment day

    The relapse free survival is defined as days from date of randomization until the date of tumor progression or the date of death causing of any reasons, and cencored at the last day of follow up when patients are alive.

  4. Quality of life differences (EORTC QLQ-C30)

    Time frame: 1st, 3rd, 6th, 12th and 24th month after enrollment

    The quality of life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) questionnaire. Patients will be invited to finish the questionnaire at the day of recruitment, 1st, 3rd, 6th, 12th and 24th month after randomization.

  5. Quality of life differences (EORTC QLQ-OES18)

    Time frame: 1st, 3rd, 6th, 12th and 24th month after enrollment

    The quality of life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-OES18) questionnaire. Patients will be invited to finish the questionnaire at the day of recruitment, 1st, 3rd, 6th, 12th and 24th month after randomization.

Study contacts

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

Xiaobin Zhang, MD

CONTACT

[email protected]

18516302162 ext. 18516302162

Zhigang Li, MD

CONTACT

[email protected]

18960619260 ext. 18960619260

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

Adjuvant Esophagectomy Versus Chemoradiation for Patients With Clinical Stage N0 and Pathological Stage T1b (After Endoscopic Submucosal Dissection, ESD) Esophageal Squamous Cell Carcinoma (Ad-ESD Trial): a Multicentric, Open Label, Randomized Trial

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Oct 22, 2019
Registry last updated
Oct 22, 2019

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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