Maintenance Chemotherapy With S-1, Locally Advanced Esophageal Cancer Receiving Definitive CCRT
- 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.
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- 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
-
an age of at least 20 years;
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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)
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an Eastern Cooperative Oncology Group performance-status score of 0-1
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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.
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adequate bone marrow, hepatic, renal and cardiac function
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Maintenance chemotherapy with S-1 regimen S-1 Maintenance chemotherapy with S-1 regimen
- Primary Outcome Measures
Name Time Method overall survival (OS) 24 months
- Secondary Outcome Measures
Name Time Method