NCT04009265 Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma
| NCT ID | NCT04009265 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fujian Medical University Union Hospital |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 819 participants |
| Start Date | 2019-08-23 |
| Primary Completion | 2022-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 819 participants in total. It began in 2019-08-23 with a primary completion date of 2022-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Chun Chen, MD
STUDY DIRECTOR
Fujian Medical University Union Hospital
Frequently Asked Questions
Who can join the NCT04009265 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04009265 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 819 participants.
Is NCT04009265 currently recruiting?
Yes, NCT04009265 is actively recruiting participants. Contact the research team at lacustrian@163.com for enrollment information.
Where is the NCT04009265 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT04009265 clinical trial?
NCT04009265 is sponsored by Fujian Medical University Union Hospital. The principal investigator is Chun Chen, MD at Fujian Medical University Union Hospital. The trial plans to enroll 819 participants.