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NCT05688033 Clinical Trial

Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy

Rectal Cancer Clinical Trial

Official title:
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During During Neoadjuvant Chemoradiation With Capecitabine and Irinotecan

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05688033
Other study ID # IMRTGI0001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 30, 2023

Study information
Verified date January 2023
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date December 30, 2023
Est. primary completion date August 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Patients with rectal adenocarcinoma 2. Clinical staged T3/4 or any node-positive disease 3. Age of 18-75 years 4. Karnofsky Performance Status > 80 5. Adequate bone marrow reserve, renal and hepatic functions 6. Without previous antitumoural chemotherapy 7. No evidence of metastatic disease 8. Written informed consent before randomization 9. UGT1A1's genotype of 6/6 or 6/7 Exclusion Criteria: 1. Clinical staged I or IV 2. Age of <18 or >75 years 3. Karnofsky Performance Status < 80 4. Previous pelvis radiotherapy 5. Previous antitumoural chemotherapy 6. Clinically significant internal disease 7. Refuse to write informed consent before randomization 8. UGT1A1's genotype of 7/7

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
dosimetric limitation of pelvic bone and peritoneal space during radiotherapy

Locations
Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Experiencing Adverse Events up to 3 years
Secondary Number of Participants in Who Experienced Tumor Down-staging up to 3 years
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