Status:
NOT_YET_RECRUITING
Maintenance Chemotherapy With S-1, Locally Advanced Esophageal Cancer Receiving Definitive CCRT
Lead Sponsor:
China Medical University Hospital
Conditions:
Locally Advanced Unresectable Esophageal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 maintena...
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...
Eligibility Criteria
Inclusion
- an age of at least 20 years;
- patients with histologically confirmed diagnosis of ESCC (Esophageal squamous cell carcinoma), GEJC (gastroesophageal junction cancer), EAC (Esophageal adenocarcinoma)
- 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)
- an Eastern Cooperative Oncology Group performance-status score of 0-1
- 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.
- adequate bone marrow, hepatic, renal and cardiac function
Exclusion
- patients had distant metastasis
- patients had esophageal perforation or esophageal fistula
- patients had tumor bleeding
- patients had severe infection
- History of malignancy other than esophageal cancer within 2 years prior to screening
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06598917
Start Date
October 1 2024
End Date
October 30 2028
Last Update
September 19 2024
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