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

Fudan University

Status: Active, not recruiting

Conditions: Rectal Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05688033

IMRTGI0001

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

experimental arm

Experimental group

Description:

peritoneal space V15\<850cc，pelvic bone V10\<80% and normal dosimetric limitation

Treatment:

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

control arm

No Intervention group

Description:

normal dosimetric limitation