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

NCT03550001 | Unknown DMC

• 1 other identifier: 2017-PKUPH077
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectal Cancer

Keywords

locally advanced rectal cancer; lymph node yeild; lymph node tracer; stage shift; prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Impact on surgical operations

  Time of surgery

• Quality of surgery

  Time of surgery

• Surgery morbidity

  30 days and 12-months

• Overall survival

  5-years

• Disease free survival

  5-years

Study Arms (2)

Injection CNP before NAT

EXPERIMENTAL

Inject carbon nanoparticle as a lymph node tracer before the patient receive neoadjuvant therapy.

Procedure: Injection CNP before NAT

No injection

NO INTERVENTION

Do not inject carbon nanoparticle during the treatment.

Interventions

Injection CNP before NAT PROCEDURE

Injection carbon nanoparticle via rectal mucosa before neoadjuvant therapy

Injection CNP before NAT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• YE Yingjiang: lead

Related Publications (17)

• Glynne-Jones R, Wyrwicz L, Tiret E, Brown G, Rodel C, Cervantes A, Arnold D; ESMO Guidelines Committee. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv22-iv40. doi: 10.1093/annonc/mdx224. No abstract available.

  PMID: 28881920 BACKGROUND

• Mechera R, Schuster T, Rosenberg R, Speich B. Lymph node yield after rectal resection in patients treated with neoadjuvant radiation for rectal cancer: A systematic review and meta-analysis. Eur J Cancer. 2017 Feb;72:84-94. doi: 10.1016/j.ejca.2016.10.031. Epub 2016 Dec 24.

  PMID: 28027520 BACKGROUND

• Gurawalia J, Dev K, Nayak SP, Kurpad V, Pandey A. Less than 12 lymph nodes in the surgical specimen after neoadjuvant chemo-radiotherapy: an indicator of tumor regression in locally advanced rectal cancer? J Gastrointest Oncol. 2016 Dec;7(6):946-957. doi: 10.21037/jgo.2016.09.03.

  PMID: 28078118 BACKGROUND

• Kim HJ, Jo JS, Lee SY, Kim CH, Kim YJ, Kim HR. Low Lymph Node Retrieval After Preoperative Chemoradiation for Rectal Cancer is Associated with Improved Prognosis in Patients with a Good Tumor Response. Ann Surg Oncol. 2015;22(6):2075-81. doi: 10.1245/s10434-014-4235-z. Epub 2014 Nov 14.

  PMID: 25395150 BACKGROUND

• Xu Z, Berho ME, Becerra AZ, Aquina CT, Hensley BJ, Arsalanizadeh R, Noyes K, Monson JRT, Fleming FJ. Lymph node yield is an independent predictor of survival in rectal cancer regardless of receipt of neoadjuvant therapy. J Clin Pathol. 2017 Jul;70(7):584-592. doi: 10.1136/jclinpath-2016-203995. Epub 2016 Dec 8.

  PMID: 27932667 BACKGROUND

• Lykke J, Jess P, Roikjaer O; Danish Colorectal Cancer Group. A minimum yield of twelve lymph nodes in rectal cancer remains valid in the era of neo-adjuvant treatment : results from a national cohort study. Int J Colorectal Dis. 2015 Mar;30(3):347-51. doi: 10.1007/s00384-015-2145-6. Epub 2015 Feb 5.

  PMID: 25652878 BACKGROUND

• Lykke J, Jess P, Roikjaer O; Danish Colorectal Cancer Group. Increased Lymph Node Yield Is Associated With Improved Survival in Rectal Cancer Irrespective of Neoadjuvant Treatment: Results From a National Cohort Study. Dis Colon Rectum. 2015 Sep;58(9):823-30. doi: 10.1097/DCR.0000000000000429.

  PMID: 26252843 BACKGROUND

• Bhangu A, Kiran RP, Brown G, Goldin R, Tekkis P. Establishing the optimum lymph node yield for diagnosis of stage III rectal cancer. Tech Coloproctol. 2014 Aug;18(8):709-17. doi: 10.1007/s10151-013-1114-8. Epub 2014 Feb 11.

  PMID: 24515286 BACKGROUND

• Carvalho C, Glynne-Jones R. Challenges behind proving efficacy of adjuvant chemotherapy after preoperative chemoradiation for rectal cancer. Lancet Oncol. 2017 Jun;18(6):e354-e363. doi: 10.1016/S1470-2045(17)30346-7.

  PMID: 28593861 BACKGROUND

• Horne J, Carr NJ, Bateman AC, Kandala N 2nd, Adams J, Silva S, Ryder I. A comparison of formalin and GEWF in fixation of colorectal carcinoma specimens: rates of lymph node retrieval and effect on TNM staging. J Clin Pathol. 2016 Jun;69(6):511-7. doi: 10.1136/jclinpath-2015-203281. Epub 2015 Nov 30.

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• Yegen G, Keskin M, Buyuk M, Kunduz E, Balik E, Saglam EK, Kapran Y, Asoglu O, Gulluoglu M. The effect of neoadjuvant therapy on the size, number, and distribution of mesorectal lymph nodes. Ann Diagn Pathol. 2016 Feb;20:29-35. doi: 10.1016/j.anndiagpath.2015.10.008. Epub 2015 Oct 29.

  PMID: 26706785 BACKGROUND

• Munster M, Hanisch U, Tuffaha M, Kube R, Ptok H. Ex Vivo Intra-arterial Methylene Blue Injection in Rectal Cancer Specimens Increases the Lymph-Node Harvest, Especially After Preoperative Radiation. World J Surg. 2016 Feb;40(2):463-70. doi: 10.1007/s00268-015-3230-2.

  PMID: 26310202 BACKGROUND

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  PMID: 23877264 BACKGROUND

• Zhang XM, Liang JW, Wang Z, Kou JT, Zhou ZX. Effect of preoperative injection of carbon nanoparticle suspension on the outcomes of selected patients with mid-low rectal cancer. Chin J Cancer. 2016 Apr 4;35:33. doi: 10.1186/s40880-016-0097-z.

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• Wang Y, Deng H, Chen H, Liu H, Xue Q, Yan J, Li G. Preoperative Submucosal Injection of Carbon Nanoparticles Improves Lymph Node Staging Accuracy in Rectal Cancer after Neoadjuvant Chemoradiotherapy. J Am Coll Surg. 2015 Nov;221(5):923-30. doi: 10.1016/j.jamcollsurg.2015.07.455. Epub 2015 Aug 20.

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MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yingjiang Ye, MD,PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingjiang Ye, MD,PhD

CONTACT

8610-88326608; yeyingjiang@pkuph.edu.cn, yjye101@sina.com

Zhidong Gao, MD

CONTACT

8610-88326605; gaozhidong@pkuph.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery, Director of Department of Gastroenterological Surgery

Model Details: Parallel

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 8, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: October 1, 2023
• Last Updated: June 8, 2018

Record last verified: 2018-05