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Phase III Study of Chemoradiotherapy with Albumin-Bound Paclitaxel and Cisplatin for Unresectable Esophageal Squamous Cell Carcinoma Using Nutritional Risk Screening
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-12-13
105
Participants Needed
5
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the one-year local tumor control rate of a chemoradiotherapy regimen combining albumin-bound paclitaxel and cisplatin in patients with unresectable esophageal squamous cell carcinoma ESCC. This Phase III study uses the Nutritional Risk Screening NRS2002 tool to select participants and manage nutritional risk factors that may influence treatment outcomes and quality of life. Participants will receive intensity-modulated radiation therapy, volume modulated arc therapy, or tomotherapy concurrently with weekly intravenous infusions of albumin-bound paclitaxel 100 mg per day and cisplatin 25 mgm2 over 5 to 6 weeks. Radiation doses are given in 28 fractions over 5.5 weeks. This treatment combination aims to control tumor growth locally while monitoring side effects. During the study, patients will undergo regular imaging scans such as CT or PET to assess tumor response and detect progression. Laboratory tests will monitor overall health and treatment side effects. Researchers will evaluate local tumor control at one year, along with secondary outcomes like survival rates, disease progression, treatment toxicity, nutritional status, and quality of life. Follow-up assessments include radiomics and ctDNA analyses to provide detailed insights into treatment effects and patient outcomes.
CONDITIONS
Brief Title
Chemoradiotherapy in Unresectable Esophageal Cancer
Research Team
X
Xin Wang, MD
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