NCT04135664RecruitingPhase 3
Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma
Adjuvant Esophagectomy Versus Chemoradiation for Patients With Clinical Stage N0 and Pathological Stage T1b (After Endoscopic Submucosal Dissection, ESD) Esophageal Squamous Cell Carcinoma (Ad-ESD Trial): a Multicentric, Open Label, Randomized Trial
Source: ClinicalTrials.gov · Last updated 22 Oct 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- First submitted
- 9 Oct 2019
- Start date
- 1 Sept 2019
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04135664
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 176
- From 1 Sept 2019 to the primary completion date, 1 Dec 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior intervention treatment before endoscopic submucosal resection.
- Prior intervention (surgery, chemoradiation, et al.) for other primary tumor disease.
Other
- Inability to accept any treatment component.
- Distant metastasis.
- The circumference of the lumen over 3/4
- Main tumor size \> 5cm assessed by endoscopy
- Inability to understand the informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Active, not recruiting |
| Shanghai Chest Hospital, Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| ChangHai Hospital, The Second Military Medical University Coordinator of this site? Confirm its status | Shanghai | China | Active, not recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Active, not recruiting |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Active, not recruiting |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.