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Clinical Trials in China / NCT04009265
Recruiting Phase 3

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

NCT04009265 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Medical University Union Hospital
Phase
Phase 3
Started
2019-08-23
Last updated
2021-11-12

Condition(s) studied

Esophageal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

adjuvant treatment

adjuvant treatment: adjuvant treatments include chemotherapy or chemoradiotherapy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participants volunteer to participate the study and signed the informed consent. 2. Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma. 3. No antineoplastic treatments before operation. 4. According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer; 5. WHO PS score: 0-1; 6. Age and gender: 18-75 years old, male and female unlimited; 7. Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements. Exclusion Criteria: 1. The surgical approach is left thoracic approach; 2. Patients with severe postoperative complications who cannot receive adjuvant therapy; 3. 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. 4. Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment; 5. 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; 6. Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response; 7. Known or suspected allergy to chemotherapeutic drugs.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting

More Fujian Medical University Union Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04009265 on ClinicalTrials.gov ↗ ← All trials in China