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NCT Number: NCT06385717

Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer

This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection.

Recruiting

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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

Observational

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Loading trial locations.

About this study

Our study can further improve the local-regional lymph nodes control rate and alleviate the toxicity of chemoradiotherapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Esophageal cancer patients who are pathologically confirmed as pT1a-MM stage or pT1b stage after endoscopic submucosal dissection； 2. No definite contraindications for chemo-radiotherapy； 3. Informed consent has been signed； 4. Refused surgery after endoscopic submucosal dissection.

Exclusion criteria

  • 1. Severe heart, brain, lung disease or renal dysfunction; 2. Previous history of other malignancies; 3. Prior radiation or chemotherapy 4. Researchers consider it inappropriate to participate in this experiment

Treatment and study plan

chemo-radiation

Radiation

different Chemo-radiotherapy regimen

Primary outcomes

  1. Incidence of toxic events

    Time frame: 2026.2

    esophageal stenosis, radiation pneumonitis, etc

Secondary outcomes

  1. 3-year overall survival

    Time frame: 2029.1

    the time from randomization until death from any cause

  2. 3-year local-regional recurrence free survival

    Time frame: 2029.1

    the time from randomization until local-regional recurrence

Study contacts

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

Jing Xu, MD

CONTACT

[email protected]

0086-0571-87783521

Qichun Wei, PHD

CONTACT

[email protected]

0086-0571-87783521

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Multicenter Cohort Study of Chemo-radiotherapy After Endoscopic Submucosal Dissection for High-risk Early-stage Esophageal Cancer

Acronym: ESCORT

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Apr 26, 2024
Registry last updated
Apr 26, 2024

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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