Rectal Cancer
Conditions
Brief 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.
Interventions
RADIATIONdosimetric limitation of pelvic bone and peritoneal space during radiotherapy
dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Adverse Events | up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants in Who Experienced Tumor Down-staging | up to 3 years |
Countries
China
Outcome results
None listed