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NCT04009265CompletedPhase 3

Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma

Multicenter Prospective Randomized Controlled Study of Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone in the Treatment of pN1-2 (pT1b-3N1-2M0) Thoracic Esophageal Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
145 (actual)
First submitted
1 Jul 2019
Start date
23 Aug 2019
Primary completion date
30 Sept 2024
Lead sponsor
Fujian Medical University Union Hospital
NCT number
NCT04009265

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 145
  • From 23 Aug 2019 to the primary completion date, 30 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The surgical approach is left thoracic approach;
  • Patients with severe postoperative complications who cannot receive adjuvant therapy;
  • Received other anti-tumor treatment before enrollment; At the same time, patients with malignant tumors of other sites were excluded, except non-melanoma skin cancer, in-situ cervical cancer or cured early prostate cancer.
  • Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment;

Other illness

  • Patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; Severe hepatic and renal insufficiency;
  • Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response;
  • Known or suspected allergy to chemotherapeutic drugs.

Who the study is looking for

  • Participants volunteer to participate the study and signed the informed consent.
  • Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma.
  • No antineoplastic treatments before operation.
  • According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer;
  • WHO PS score: 0-1;
  • Age and gender: 18-75 years old, male and female unlimited;
  • Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fujian Medical University Union Hospital
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.