Esophageal Squamous Cell Carcinoma
Conditions
Keywords
esophageal squamous cell carcinoma, adjuvant chemotherapy, adjuvant chemoradiotherapy, surgery
Brief 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.
Detailed description
A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone on the overall survival rate (OS) and disease-free survival (DFS) of patients with pN1-2 (pT1b-3N1-2M0) thoracic esophageal squamous cell carcinoma, and to observe the safety, side effects of adjuvant therapy and the impact on the quality of life of patients after operation.
Interventions
COMBINATION_PRODUCTadjuvant treatment
adjuvant treatments include chemotherapy or chemoradiotherapy
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 3-year overall survival | overall survival rate of each arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival | 3-year disease free survival | Disease free survival rate of each arms |
| Adverse Events | 1 year | Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) |
| Scores of Quality of Life | 5 years | Assess the quality of life based on EORTC QLQ-C30 and OES18 |
Countries
China
Contacts
Primary ContactBin Zheng, MD
Outcome results
None listed