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

Not Applicable

Active, not recruiting

• Conditions: Rectal Cancer
• Interventions: Radiation: dosimetric limitation of pelvic bone and peritoneal space during radiotherapy

• Registration Number: NCT05688033
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study Start: 2021-01-01
• Primary Completion: 2022-08-30
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-08
• Last Update Submitted: 2023-01-08
• Study First Posted: 2023-01-18
• Last Update Posted: 2023-01-18
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental arm	dosimetric limitation of pelvic bone and peritoneal space during radiotherapy	peritoneal space V15\<850cc，pelvic bone V10\<80% and normal dosimetric limitation

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Adverse Events	up to 3 years

Secondary Outcome Measures

Name	Time	Method
Number of Participants in Who Experienced Tumor Down-staging	up to 3 years

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China