Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy (CALOR-NAT)

May 25, 2018 updated by: YE Yingjiang

Prospective Randomized Clinical Trial of Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy

The purpose of this study is to evaluate whether injection of carbon nanoparticle as a lymph node tracer before neoadjuvant radiochemotherapy in rectal cancer can increase lymph node yield after surgery compared which do not inject.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is the randomized controlled, multi-centers，and open-labeled study. The lymph node yield was significantly decreased in rectal cancer after neoadjuvant radiochemotherapy (NAT), hard for pathologists to detect, and is difficult to meet the guideline that minimun of 12 lymph nodes should be retrived after surgery in colorectal cancer. Carbon nanoparticle (CNP) is a specific lymph node tracer, which only dyeing the lymph node, and can keep the lymph node in dyeing state in at least half year. The inverstigator attempted to compare the amount of lymph node yield after surgery in locally advanced rectal caner between injection CNP before NAT and no injection CNP before NAT. In this study, the participants with clinical TNM stage T3+ or N+ will be recruited. The participants will be randomized (1:1 ratio) to a control and intervention arm. The participants in the control arm will not receive injection of any kind lymph node tracers. The participants in the intervention arm will receive injection of CNP before NAT. And the specimen would be evaluated by the pathologist.

Study Type

Interventional

Enrollment (Anticipated)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 18-75 years old;
  2. Histologically confirmed adenocarcinoma;
  3. The rectal adenocarcinoma 0-12cm from the anal margin;
  4. Clinical TNM stage: T3+ or N+;
  5. Untreated patients (who have not received treatment including radiotherapy, chemotherapy, and surgery);
  6. Good liver and kidney function, without contraindications for radiotherapy, chemotherapy or surgery;
  7. Able and willing to give informed consent to participate;

Exclusion Criteria:

  1. Malignant tumor history or other malignant tumors;
  2. Emergency operations such as intestinal obstruction, perforation and hemorrhage;
  3. Pregnant or lactating women;
  4. History of severe mental illness;
  5. Contraindications for radiotherapy, chemotherapy and surgery;
  6. Conditions that the researcher thinks it is not suitable for selection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Injection CNP before NAT
Inject carbon nanoparticle as a lymph node tracer before the patient receive neoadjuvant therapy.
Procedure: Injection CNP before NAT
Injection carbon nanoparticle via rectal mucosa before neoadjuvant therapy
NO_INTERVENTION: No injection
Do not inject carbon nanoparticle during the treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lymph node yield
Time Frame: up to 30days after total mesorectal excision
Amount of lymph node yield, dyeing lymph node, positive lymph node and the dyeing positive lymph node
up to 30days after total mesorectal excision

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on surgical operations
Time Frame: Time of surgery
The impact of CNP to operational level
Time of surgery
Quality of surgery
Time Frame: Time of surgery
Quality of surgery determined using the mesorectal grading system
Time of surgery
Surgery morbidity
Time Frame: 30 days and 12-months
Surgical morbidity reported according to Clavien-Dindo classification
30 days and 12-months
Overall survival
Time Frame: 5-years
Overall Survival is defined as the time from the date of surgery to the date of death
5-years
Disease free survival
Time Frame: 5-years
Disease Free Survival is defined as the time from the date of surgery to the date of the local recurrence, and/or distant disease, or tumor-related death
5-years
Local recurrence rate
Time Frame: 5-years
Local recurrence rate is defined as the time from the date of surgery to the date of the local recurrence
5-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YE Yingjiang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2018

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (ACTUAL)

June 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-PKUPH077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We need to discuss with other centers, then decide whether to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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