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Trial Title:
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy
NCT ID:
NCT05688033
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
Description:
dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
Arm group label:
experimental arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Start date:
January 1, 2021
Completion date:
December 30, 2023
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05688033
