Clinical trial NCT04135664: Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Esophageal Cancer
Keywords: esophagectomy
chemoradiation
esophageal cancer
endoscopic submucosal dissection
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

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.

Primary outcomes:
measure: 5-year overall survival rate
timeFrame: 5 years after enrollment day
Secondary outcomes:
measure: 3-year overall survival rate
timeFrame: 3 years after enrollment day
measure: 3-year relapse free survival rate
timeFrame: 3 years after enrollment day
measure: 5-year relapse free survival rate
timeFrame: 5 years after enrollment day
measure: Quality of life differences (EORTC QLQ-C30)
timeFrame: 1st, 3rd, 6th, 12th and 24th month after enrollment
measure: Quality of life differences (EORTC QLQ-OES18)
timeFrame: 1st, 3rd, 6th, 12th and 24th month after enrollment
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Changhai Hospital, The Second Military Medical University
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
city: Shanghai
country: China
facility: Shanghai Chest Hospital, Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
affiliation: Shanghai Chest Hospital of Shanghai Jiao Tong University
name: Zhigang Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.