Chemoradiotherapy Sequenced Radical Surgery for Colorecta... | NCT05129774

Studies
Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

NCT05129774

Sponsor

Qilu Hospital of Shandong University

Status

Not yet recruiting

Last Update Posted

Nov 22, 2021Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Colorectal Neoplasms Malignant
Lymph Node Excision
Chemoradiotherapy

Interventions

Radical surgery with PALND
Radical surgery without PALND

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Estimated

Primary Completion Date

Jan 1, 2024Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Oct 28, 2021

First Submission Date that Met QC Criteria

Nov 18, 2021

First Posted Date

Nov 22, 2021Actual

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

Nov 18, 2021

Last Update Posted Date

Nov 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

In left-sided colon and rectal cancer, the occurrence of synchronous para-aortic lymph node metastasis is rare, with the incidence of being approximate 1-2%. Currently, there has been no standard treatment strategy for this situation. The present trial is designed to evaluate the safety and efficacy of para-aortic lymph node dissection for left-sided colon and rectal cancer with synchronous para-aortic lymph node metastasis

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
radical surgery with PALND	Experimental		Procedure: Radical surgery with PALND
radical surgery without PALND	Active Comparator		Procedure: Radical surgery without PALND

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radical surgery with PALND	Procedure	sufficient resection margins of the tumor, D3 dissection of the regional lymph nodes and para-aortic lymph node dissection from the bifurcation of iliac artery to the left renal vein via laparoscopic approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
5-year OS	5-year overall survival	From date of recruitment until the date of death from any cause, assessed up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
DFS	5-year disease-free survival	From date of recruitment until the date of disease recurrece, assessed up to 5 years
LFFS	Local failure free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age at enrollment is ≥ 18 and ≤ 75 years
ECOG PS 0-1
histologically confirmed left-sided colon and rectal carcinoma
synchronous para-aortic lymph node metastases confirmed by PET-CT, and located below the level of renal veins and above the bifurcation of iliac artery
patients potential to receive surgery and achieve no evidence of disease (NED)
able to tolerate surgery
providing written informed consent

Exclusion Criteria:

local invasion or distant metastasis other than para-aoritc lymph nodes
history of other malignant tumor
coupled with severe systematic diseases (recent myocardial infarction, cardiomyopathy, or acute pulmonary infection)
emergency surgery

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

Name	Role	Phone	Extension	Email
Yong Dai, M.D. Ph.D.	Contact	+8618560085117		yongdai@hotmail.com
Xiang Zhang, M.D. Ph.D.	Contact	+8618560089182		xiang.zhang02@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qilu Hospital of Shandong University		Jinan	Shandong	250012	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

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

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Browse Branches

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