Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Injection CNP before NAT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-75 years old; Histologically confirmed adenocarcinoma; The rectal adenocarcinoma 0-12cm from the anal margin; Clinical TNM stage: T3+ or N+; Untreated patients (who have not received treatment including radiotherapy, chemotherapy, and surgery); Good liver and kidney function, without contraindications for radiotherapy, chemotherapy or surgery; Able and willing to give informed consent to participate; Exclusion Criteria: Malignant tumor history or other malignant tumors; Emergency operations such as intestinal obstruction, perforation and hemorrhage; Pregnant or lactating women; History of severe mental illness; Contraindications for radiotherapy, chemotherapy and surgery; Conditions that the researcher thinks it is not suitable for selection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lymph node yield | 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 | The impact of CNP to operational level | Time of surgery | 
| Quality of surgery | Quality of surgery determined using the mesorectal grading system | Time of surgery | 
| Surgery morbidity | Surgical morbidity reported according to Clavien-Dindo classification | 30 days and 12-months | 
| Overall survival | Overall Survival is defined as the time from the date of surgery to the date of death | 5-years | 
| Disease free survival | 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 | Local recurrence rate is defined as the time from the date of surgery to the date of the local recurrence | 5-years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locally advanced rectal cancer, lymph node yeild, lymph node tracer, stage shift, prognosis