Comparing treatments for esophageal cancer
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
This study is testing which treatment—chemotherapy, chemoradiotherapy, or surgery alone—works best for people with esophageal cancer to help them live longer and feel better after their treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 819 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT04009265 on ClinicalTrials.gov |
What this trial studies
This study is a multi-center prospective randomized controlled trial aimed at comparing the effects of adjuvant chemotherapy, chemoradiotherapy, and surgery alone on patients with thoracic esophageal squamous cell carcinoma. It focuses on evaluating overall survival rates and disease-free survival, while also assessing the safety, side effects, and quality of life impacts of the different treatment approaches. Participants will undergo radical tumor resection followed by one of the adjuvant treatments, with careful monitoring of their health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with pN1-2 stage thoracic esophageal squamous cell carcinoma who have undergone radical resection.
Not a fit: Patients with severe postoperative complications or those who have received prior anti-tumor treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment approach for improving survival and quality of life in patients with esophageal cancer.
How similar studies have performed: Other studies have explored similar treatment comparisons in esophageal cancer, indicating potential for meaningful advancements in patient care.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Bin Zheng, MD
- Email: lacustrian@163.com
- Phone: +8659186218408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.