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

NCT05688033 | Unknown DMC

• 1 other identifier: IMRTGI0001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Adverse Events

  up to 3 years

Secondary Outcomes (1)

• Number of Participants in Who Experienced Tumor Down-staging

  up to 3 years

Study Arms (2)

experimental arm

EXPERIMENTAL

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

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

control arm

NO INTERVENTION

normal dosimetric limitation

Interventions

dosimetric limitation of pelvic bone and peritoneal space during radiotherapy RADIATION

dosimetric limitation of pelvic bone and peritoneal space during radiotherapy

experimental arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with rectal adenocarcinoma
• Clinical staged T3/4 or any node-positive disease
• Age of 18-75 years
• Karnofsky Performance Status \> 80
• Adequate bone marrow reserve, renal and hepatic functions
• Without previous antitumoural chemotherapy
• No evidence of metastatic disease
• Written informed consent before randomization
• UGT1A1's genotype of 6/6 or 6/7

You may not qualify if:

• Clinical staged I or IV
• Age of \<18 or \>75 years
• Karnofsky Performance Status \< 80
• Previous pelvis radiotherapy
• Previous antitumoural chemotherapy
• Clinically significant internal disease
• Refuse to write informed consent before randomization
• UGT1A1's genotype of 7/7

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Zhen Zhang

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: January 18, 2023
• Study Start: January 1, 2021
• Primary Completion: August 30, 2022
• Study Completion: December 30, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)