NCT04135664 Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma
| NCT ID | NCT04135664 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Chest Hospital |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2027-12-01 |
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 176 participants in total. It began in 2019-09-01 with a primary completion date of 2027-12-01.
⚠ 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
The ad-ESD trial is phase III randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage N0 and pathological stage T1b squamous cell carcinoma (after endoscopic submucosal dissection).
Eligibility Criteria
Inclusion Criteria: * Biopsy proven with esophageal squamous cell cancer. * Clinical N0 stage diagnosed by imaging examinations. * Pathological T1b stage confirmed by endoscopic submucosal dissection. * Age: 18-75. * Tumor located at the thorax. * Performance status Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Written informed consent. Exclusion Criteria: * Prior intervention treatment before endoscopic submucosal resection. * Inability to accept any treatment component. * Prior intervention (surgery, chemoradiation, et al.) for other primary tumor disease. * Distant metastasis. * The circumference of the lumen over 3/4 * Main tumor size \> 5cm assessed by endoscopy * Inability to understand the informed consent.
Contact & Investigator
Zhigang Li, MD, PhD
PRINCIPAL INVESTIGATOR
Shanghai Chest Hospital of Shanghai Jiao Tong University
Frequently Asked Questions
Who can join the NCT04135664 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Cancer. 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 NCT04135664 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 176 participants.
Is NCT04135664 currently recruiting?
Yes, NCT04135664 is actively recruiting participants. Contact the research team at dr_lizhigang@163.com for enrollment information.
Where is the NCT04135664 trial being conducted?
This trial is being conducted at Nanchang, China, Shanghai, China, Shanghai, China, Shanghai, China and 2 additional locations.
Who is sponsoring the NCT04135664 clinical trial?
NCT04135664 is sponsored by Shanghai Chest Hospital. The principal investigator is Zhigang Li, MD, PhD at Shanghai Chest Hospital of Shanghai Jiao Tong University. The trial plans to enroll 176 participants.
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