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

Fudan University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Rectal Cancer

Interventions

dosimetric limitation of pelvic bone and peritoneal space during radiotherapyRADIATION

dosimetric limitation of pelvic bone and peritoneal space during radiotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Number of Participants Experiencing Adverse Events

Time frame: up to 3 years

Secondary Outcomes

Number of Participants in Who Experienced Tumor Down-staging

Time frame: up to 3 years

Data from ClinicalTrials.gov

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