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

NCT ID: NCT05688033

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-12-30

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental arm

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

Group Type: EXPERIMENTAL

dosimetric limitation of pelvic bone and peritoneal space during radiotherapy

Intervention Type: RADIATION

dosimetric limitation of pelvic bone and peritoneal space during radiotherapy

control arm

normal dosimetric limitation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

dosimetric limitation of pelvic bone and peritoneal space during radiotherapy

dosimetric limitation of pelvic bone and peritoneal space during radiotherapy

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhen Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhen Zhang

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

IMRTGI0001

Identifier Type: -

Identifier Source: org_study_id