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

January 8, 2023 updated by: Zhen Zhang, Fudan University

Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During During Neoadjuvant Chemoradiation With Capecitabine and Irinotecan

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental arm
peritoneal space V15<850cc，pelvic bone V10<80% and normal dosimetric limitation
Radiation: dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
No Intervention: control arm
normal dosimetric limitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Experiencing Adverse Events
Time Frame: up to 3 years
up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants in Who Experienced Tumor Down-staging
Time Frame: up to 3 years
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Zhen Zhang, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

August 30, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

January 8, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 8, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMRTGI0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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