Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

NCT ID: NCT05129774

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2027-01-01

Brief Summary

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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

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Conditions

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Colorectal Neoplasms Malignant Lymph Node Excision Chemoradiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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radical surgery with PALND

Group Type EXPERIMENTAL

Radical surgery with PALND

Intervention Type 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

radical surgery without PALND

Group Type ACTIVE_COMPARATOR

Radical surgery without PALND

Intervention Type PROCEDURE

surgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND

Interventions

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Radical surgery with PALND

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

Intervention Type PROCEDURE

Radical surgery without PALND

surgery includes sufficient resection margins of the tumor and D3 dissection of the regional lymph nodes without PALND

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Yong Dai, M.D. Ph.D.

Role: CONTACT

Phone: +8618560085117

Email: [email protected]

Xiang Zhang, M.D. Ph.D.

Role: CONTACT

Phone: +8618560089182

Email: [email protected]

Facility Contacts

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Xiang Zhang

Role: primary

Yanlei Wang

Role: backup

Other Identifiers

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V123456

Identifier Type: -

Identifier Source: org_study_id