Back to resultsDosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy
Primary Purpose
Rectal Cancer
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental arm
control arm
Arm Description
peritoneal space V15<850cc，pelvic bone V10<80% and normal dosimetric limitation
normal dosimetric limitation
Outcomes
Primary Outcome Measures
Number of Participants Experiencing Adverse Events
Secondary Outcome Measures
Number of Participants in Who Experienced Tumor Down-staging
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05688033
Brief Title
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy
Official Title
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During During Neoadjuvant Chemoradiation With Capecitabine and Irinotecan
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental arm
Arm Type
Experimental
Arm Description
peritoneal space V15<850cc，pelvic bone V10<80% and normal dosimetric limitation
Arm Title
control arm
Arm Type
No Intervention
Arm Description
normal dosimetric limitation
Intervention Type
Radiation
Intervention Name(s)
dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
Intervention Description
dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Adverse Events
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Number of Participants in Who Experienced Tumor Down-staging
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Zhang
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy
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