Adjuvant Therapies or Surgery Alone for High Risk pN0 Esophageal Cancer

Esophageal Neoplasms Clinical Trial

Official title: Multi-center Prospective Randomized Controlled Clinical Trial of Postoperative Adjuvant Chemotherapy, Adjuvant Radiotherapy, or Surgery Alone for High-risk Histological Node Negative Patients With Thoracic Esophageal Squamous Cell Carcinoma

Status Recruiting

Clinical Trial Summary

Histological Node Negative thoracic esophageal squamous cell carcinoma（pN0 ESCC） after radical resection still carries the risk of recurrence after complete surgical resection, especially in some high-risk patients. There are still lack of knowledge on postoperative treatment indication and methods for pN0 ESCC.Our previous study has shown that risk of recurrence is associated with the location and cell differentiation of primary tumor, as well as the presence of lymphovascular invasion. This project is designed to study the efficacy of adjuvant therapies for at patients with pN0 ESCC and above mentioned risk factors of recurrence after radical surgery. We aim to compare the differences among adjuvant chemotherapy, adjuvant radiotherapy, and surgery alone for pN0 ESCC by prospective randomized controlled trial. There has been no similar studies in esophageal cancer previously reported with similar design. The results of this study is expected to have a high clinical relevance.

Clinical Trial Description

The study is designed to be a prospective randomized controlled trial, aiming to compare the impact of adjuvant chemotherapy with Paclitaxel and Cisplatin, adjuvant radiotherapy with IMRT of 50Gy, and surgery alone on the disease free survival (DFS) of patients with high-risk pN0 thoracic esophageal squamous cell carcinoma. Pathological staging is to be based on the 7th UICC edition, after radical resection and systemic lymph node dissection,for accurate staging.Patients with pT1b-T4a disease, proved to be pN0 upon pathological examination, meet at least one of the risk factors in the inclusion criteria, and without any exclusion criteria are to be randomized into one of the three study arms.Definition of high-risk factors for recurrence include: (1)Tumor location: in the middle or upper third thoracic esophagus; (2) Presence of LVI or submucosal metastasis; (3) Cell differentiation: poorly differentiated or undifferentiated.

Primary endpoint:

To observe and compare Disease-Free Survivals (DFS) among the three study arms.

Secondary endpoint:

To observe and compare Overall Survivals (OS) among the three study arms, and to compare adverse events between adjuvant chemotherapy and adjuvant radiation groups.

Additional instructions:

No. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasms

• NCT number: NCT02891083
• Study type: Interventional
• Source: Shanghai Chest Hospital
• Contact: Wentao Fang, MD
• Phone: +86-21-62821990
• Email: vwtfang12@shcheat.org
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2016
• Completion date: January 2021