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NCT05688033
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy
Conditions: Rectal Cancer
Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 200
Sponsor: Fudan University
Location: China
Summary
This project first retrospectively analyzes the intestinal dose indicators related to the concurrent radiotherapy and chemotherapy of rectal cancer and gastrointestinal toxicity, and the pelvic dose indicators related to hematological toxicity, and then prospectively conducts radiotherapy based on the dose indicators most closely related to toxicity.
The dose is limited when the plan is made to reduce the gastrointestinal and hematological toxicity of rectal cancer with concurrent radiotherapy and chemotherapy.
Eligibility Criteria
Inclusion Criteria:Patients with rectal adenocarcinomaClinical staged T3/4 or any node-positive diseaseAge of 18-75 yearsKarnofsky Performance Status > 80Adequate bone marrow reserve, renal and hepatic functionsWithout previous antitumoural chemotherapyNo evidence of metastatic diseaseWritten informed consent before randomizationUGT1A1's genotype of 6/6 or 6/7Exclusion Criteria:Clinical staged I or IVAge of <18 or >75 yearsKarnofsky Performance Status < 80Previous pelvis radiotherapyPrevious antitumoural chemotherapyClinically significant internal diseaseRefuse to write informed consent before randomizationUGT1A1's genotype of 7/7
Source: ClinicalTrials.gov (NCT05688033). StuddyBuddy aggregates publicly available trial information.