Dosimetric Limitation of Pelvic Bone and Peritoneal Space... | NCT05688033

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

NCT05688033

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Jan 18, 2023Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Rectal Cancer

Interventions

dosimetric limitation of pelvic bone and peritoneal space during radiotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Oct 29, 2020

First Submission Date that Met QC Criteria

Jan 8, 2023

First Posted Date

Jan 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2023

Last Update Posted Date

Jan 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
dosimetric limitation of pelvic bone and peritoneal space during radiotherapy	Radiation	dosimetric limitation of pelvic bone and peritoneal space during radiotherapy	experimental arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhen Zhang	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center		Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided