Adjuvant Radiotherapy for pT1b Esophageal Cancer After Submucosal Endoscopic Resection

NCT05499195 | Completed

• 1 other identifier: NCC2690
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic Resection (ER) is a crucial therapeutic and diagnostic method for superficial esophageal cancer. However, lymph node metastasis rate in pT1b patients is relatively high. Although, adjuavnt chemoradiotherapy is recommended, limied studies prove the superiority of additional adjuvant radiotherapy over ESD alone. This study aimed to further verify the efficacy of adjuvant radiotherapy in early-stage esophageal cancer after ESD.

Conditions

Esophageal Cancer

Keywords

early-stage; submucosal endoscopic resection; adjuvant radiotherapy

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  OS was defined as the duration between diagnosis and any cause of death.

  3-year

• Disease-free Survival (DFS)

  DFS was defined as the duration between the diagnosis and any disease recurrence or any cause of death, whichever occurred first.

  3-year

Study Arms (2)

ESD group

ESD was performed by a highly experienced endoscopist who underwent systemic training. First, the endoscopist carried out chromoendoscopy by spraying 1.25% Lugol's iodine solution to identify the lesion and made dots with a dual-knife outside the margin of the lesion. Next, a forward-viewing endoscope was introduced with a transparent cap attachment on its tip. A saline solution with methylene blue and epinephrine was injected into the submucosa with an injection needle to create a liquid cushion separating the lesion and the muscle layer. Then, a mucosal incision at the periphery of the marking dots was performed with a dual-knife. After that, the submucosal connective tissue beneath the lesion was dissected using the same dual-knife, and the lesion was totally removed through dissection.

ESD+adjuvant radiotherapy group

The process of ESD was the same as that of ESD group. A total dose of 41.4-60.0 Gy in common fractionation based on three-dimensional conformal radiotherapy or intensity modulated radiotherapy technology was prescribed.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who met the inclusion and exclusion Criteria treated in 11 hospitals in China were included.

You may qualify if:

• (1) ECOG score \< 2; (2) Pathologically confirmed squamous or adenosquamous cell cancer; (3) Clinical stage cTis-1bN0M0; (4) Multiple primary T1 lesions were allowed; (5) No lymph nodes and distant metastases confirmed by chest CT, neck CT or neck ultrasound, and abdominal CT or abdominal ultrasound; (6) Underwent ESD between January 2010 and December 2019; (7) pT1b disease confirmed by endoscopically resected specimen; (8) Underwent adjuvant radiotherapy (with or without chemotherapy) or surveillance after ESD.

You may not qualify if:

• (1) Diagnosed with other locally-advanced or advanced malignancies within 3 years before ESD; (2) Underwent radical surgery after ESD; (3) Upfront radiotherapy, chemotherapy or chemoradiotherapy before ESD; (4) Lost to follow-up or insufficient clinical information.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Director of VIP Department

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: March 1, 2021
• Primary Completion: May 15, 2022
• Study Completion: June 30, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)