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

Recruiting now · Phase 3

Conditions studied: Esophageal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT04009265

Run by

Fujian Medical University Union Hospital

People needed

819

Starts

2019-08-23

Expected to finish

2027-07-01

Last updated by the study team

2021-11-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• 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.

Where it is running

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)

Full record on ClinicalTrials.gov

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