Maintenance Chemotherapy With S-1, Locally Advanced Esophageal Cancer Receiving Definitive CCRT

Phase 2
Not yet recruiting
Conditions
Interventions
Registration Number
NCT06598917
Lead Sponsor
China Medical University Hospital
Brief Summary

Phase II study of definitive concurrent chemoradiotherapy follows consolidative chemotherapy with S1 for locally advanced unresectable esophageal cancer.

Our treatment strategy is to perform maintenance chemotherapy with S-1 in patients with locally advanced esophageal cancer receiving dCCRT.
...

Detailed Description

Esophageal cancer is an aggressive malignant disease, ranking seventh in incidence and sixth in mortality among all cancers. The lack of a serosa layer in the esophagus allows tumor regional spread to nearby organs and lymph nodes. While radical surgery was historically the preferred treatment for esophageal cancer, 50% to 60% of patients are deemed unsuitab...

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
60
Inclusion Criteria
  1. an age of at least 20 years;

  2. patients with histologically confirmed diagnosis of ESCC (Esophageal squamous cell carcinoma), GEJC (gastroesophageal junction cancer), EAC (Esophageal adenocarcinoma)

  3. stage II-IVA, AJCC, 8th, locally advanced disease is suitable for dCCRT and is ineligible for curative surgery (including those who are unable or unwilling to undergo surgery)

  4. an Eastern Cooperative Oncology Group performance-status score of 0-1

  5. definitive concurrent chemoradiotherapy according to regional oncology guidelines for esophageal cancer, with the following criteria:

    • patients must have received platinum-based chemotherapy (at least 2 cycles of tri-weekly regimen or at least 4 cycles of weekly regimen) and radiation therapy consistent with definitive treatment (50-64 Gy)
    • no evidence of radiographic disease progression per RECIST v1.1, as documented by comparison of scans (pre- and post-definitive concurrent chemoradiotherapy) prior to enrollment.
  6. adequate bone marrow, hepatic, renal and cardiac function

Read More
Exclusion Criteria
  1. patients had distant metastasis
  2. patients had esophageal perforation or esophageal fistula
  3. patients had tumor bleeding
  4. patients had severe infection
  5. History of malignancy other than esophageal cancer within 2 years prior to screening
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Maintenance chemotherapy with S-1 regimenS-1Maintenance chemotherapy with S-1 regimen
Primary Outcome Measures
NameTimeMethod
overall survival (OS)24 months
Secondary Outcome Measures
NameTimeMethod
© Copyright 2024. All Rights Reserved by MedPath