Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: esophagectomy, chemoradiation, active surveillance.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
Detailed description
Esophagectomy is still the primary treatment for pathological T1b esophageal squamous cell carcinoma. However, esophagectomy is associated with high mortality and morbidity and decreased quality of life. Endoscopic resection followed with chemoradiation had showed uncompromised oncological outcomes with esophagectomy. But there is no well-designed, phase III trial to compare the two treatment for patients with pT1b squamous cell carcinoma.
The ad-ESD trial is a multi-center prospective superiority trial, combied of a randomized clinical trial and a prospective registry.
The experimental design produces two randomized arms; (1) esophagectomy and (2) chemoradiation. An additional registry arm will be based on surgeons/patients that do not want to be randomised because of their own experience on adjuvant therapy, including esophagectomy; chemoradiation and active surveillance.
The primary endpoint is to evaluate the difference of 5-year overall survival rate between definitive chemoradiation and esophagectomy, in patients with cN0-pT1b esophageal squamous cell cancer (ESCC) after endoscopic resection.
The secondary endpoints are to evaluate the difference of quality of life and oncological outcomes including 3-year overall survival (OS) and 3, 5-year relapse free survival (RFS) between the two treatments.
Interventions
- Procedure esophagectomy
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy - Combination product chemoradiation
concurrent chemotherapy and radiotherapy - Other active surveillance
No further adjuvant therapy
Primary outcome measures
- 5-year overall survival rate [Time frame: 5 years after enrollment day]
Secondary outcome measures (5)
- 3-year overall survival rate [Time frame: 3 years after enrollment day]
- 3-year relapse free survival rate [Time frame: 3 years after enrollment day]
- 5-year relapse free survival rate [Time frame: 5 years after enrollment day]
- Quality of life differences (EORTC QLQ-C30) [Time frame: 1st, 3rd, 6th, 12th and 24th month after enrollment]
- Quality of life differences (EORTC QLQ-OES18) [Time frame: 1st, 3rd, 6th, 12th and 24th month after enrollment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 6 centers
- The First Affiliated Hospital of Nanchang University — Nanchang
- Changhai Hospital, The Second Military Medical University — Shanghai
- Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine — Shanghai
- Shanghai Chest Hospital, Shanghai Jiao Tong University — Shanghai
- Zhongshan Hospital, Fudan University — Shanghai
- Tianjin Medical University Cancer Institute and Hospital — Tianjin
Publications
- Yang Y, Su Y, Zhang X, Liu J, Zhang H, Li B, Hua R, Tan L, Chen H, Li Z. Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial). Trials. 2020 Jul 1;21(1):603. doi: 10.1186/s13063-020-04461-5. PMID 32611448
Identifiers
NCT: NCT04135664 · Chest201908