Systemic Therapy Sequenced Isolated PALND for mCRC | NCT04774757

Studies
Systemic Therapy Sequenced Isolated PALND for mCRC

NCT04774757

Sponsor

First Affiliated Hospital of Zhejiang University

Status

Unknown status

Last Update Posted

Oct 11, 2021Actual

Enrollment

39Estimated

Phase

Not Applicable

Conditions

Synchronous Isolated Para-aortic Lymph Node Metastasis
Colorectal Cancer

Interventions

Para-aortic lymph node dissection

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2021Actual

Primary Completion Date

Mar 1, 2023Estimated

Completion Date

Mar 1, 2026Estimated

First Submitted Date

Feb 25, 2021

First Submission Date that Met QC Criteria

Feb 25, 2021

First Posted Date

Mar 1, 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

Oct 4, 2021

Last Update Posted Date

Oct 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The study aims to estimate the efficacy and safety of systemic therapy sequenced radical surgery in treating patients with synchronous isolated para-aortic lymph node metastasis of colorectal cancer.

Detailed Description

Patients with synchrnous isolated para-aortic lymph node metastasis of colorectal cancer receiving systemtic therapy (at most two lines), radiologically assessed efficacious, and assessed by MDT that are potential to reach no evidence of disease (NED) were included in our trial. All included patients receive para-aortic lymph node dissection.

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

39Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Systemic therapy sequenced PALND	Experimental	All received systemtic therapy (at most two lines).	Procedure: Para-aortic lymph node dissection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Para-aortic lymph node dissection	Procedure	Para-aortic lymph node dissection was defined as the dissection of para-aortic lymph nodes located below renal vein and above the bifurcation of iliac artery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3-year DFS	Time with no recurrence of the diseases.	From date of recruiment until the date of disease recurrece, assessed up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
5-year OS	From date of recruitment until the date of death from any cause, assessed up to 5 years.	Up to 5 years
LFS	Time with no recurrence of the paraaortic lymph node region.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age at enrollment is >= 18 and <= 75 years
ECOG PS 0-1
Histologically confirmed colorectal carcinoma
Synchronous metastatic colorectal cancer with isolated para-aortic lymph node metastases: In the preoperative examination of positron emission tomography CT and abdominopelvic CT, metastasis was noted when the diameter of the PALN was 10 mm or greater and had irregular shape.
Single-organ para-aortic lymph node metastasis (PLANM) who are potential to receive surgery and achieve no evidence of disease (NED).
Adequate liver, renal and bona marrow function.
Signing written informed consent

Exclusion Criteria:

In addition to PALN metastasis, distant metastases such as lung, liver, peritoneum and bone were presen and in instances when the renal vein was in the upward spread path of the LN metastasis.
Unable to achieve NED
Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months.
Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
Organ transplantation requires immunosuppressive therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guosheng Wu, MD	Contact	+8617857310313		guosheng_wu@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital, Zhejiang University School of Medicine	Recruiting	Hangzhou	Zhejiang	310006	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

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site