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

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: Injection CNP before NAT

• Registration Number: NCT03550001
• Lead Sponsor: YE Yingjiang

Brief Summary

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

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 Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-05-25
• Last Update Submitted: 2018-05-25
• Study Start: 2018-06-01
• Study First Posted: 2018-06-08
• Last Update Posted: 2018-06-08
• Primary Completion: 2019-06-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 252

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection CNP before NAT	Injection CNP before NAT	Inject carbon nanoparticle as a lymph node tracer before the patient receive neoadjuvant therapy.

Primary Outcome Measures

Name	Time	Method
lymph node yield	up to 30days after total mesorectal excision	Amount of lymph node yield, dyeing lymph node, positive lymph node and the dyeing positive lymph node

Secondary Outcome Measures

Name	Time	Method
Impact on surgical operations	Time of surgery	The impact of CNP to operational level
Quality of surgery	Time of surgery	Quality of surgery determined using the mesorectal grading system
Surgery morbidity	30 days and 12-months	Surgical morbidity reported according to Clavien-Dindo classification
Overall survival	5-years	Overall Survival is defined as the time from the date of surgery to the date of death
Disease free survival	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
Local recurrence rate	5-years	Local recurrence rate is defined as the time from the date of surgery to the date of the local recurrence