search
Back to results

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

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Injection CNP before NAT
Sponsored by
YE Yingjiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rectal Cancer focused on measuring locally advanced rectal cancer, lymph node yeild, lymph node tracer, stage shift, prognosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Injection CNP before NAT

    No injection

    Arm Description

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

    Do not inject carbon nanoparticle during the treatment.

    Outcomes

    Primary Outcome Measures

    lymph node yield
    Amount of lymph node yield, dyeing lymph node, positive lymph node and the dyeing positive lymph node

    Secondary Outcome Measures

    Impact on surgical operations
    The impact of CNP to operational level
    Quality of surgery
    Quality of surgery determined using the mesorectal grading system
    Surgery morbidity
    Surgical morbidity reported according to Clavien-Dindo classification
    Overall survival
    Overall Survival is defined as the time from the date of surgery to the date of death
    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
    Local recurrence rate
    Local recurrence rate is defined as the time from the date of surgery to the date of the local recurrence

    Full Information

    First Posted
    May 25, 2018
    Last Updated
    May 25, 2018
    Sponsor
    YE Yingjiang
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03550001
    Brief Title
    Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy
    Acronym
    CALOR-NAT
    Official Title
    Prospective Randomized Clinical Trial of Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2018 (Anticipated)
    Primary Completion Date
    June 1, 2019 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    YE Yingjiang

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer
    Keywords
    locally advanced rectal cancer, lymph node yeild, lymph node tracer, stage shift, prognosis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel
    Masking
    None (Open Label)
    Masking Description
    Open label
    Allocation
    Randomized
    Enrollment
    252 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Injection CNP before NAT
    Arm Type
    Experimental
    Arm Description
    Inject carbon nanoparticle as a lymph node tracer before the patient receive neoadjuvant therapy.
    Arm Title
    No injection
    Arm Type
    No Intervention
    Arm Description
    Do not inject carbon nanoparticle during the treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    Injection CNP before NAT
    Intervention Description
    Injection carbon nanoparticle via rectal mucosa before neoadjuvant therapy
    Primary Outcome Measure Information:
    Title
    lymph node yield
    Description
    Amount of lymph node yield, dyeing lymph node, positive lymph node and the dyeing positive lymph node
    Time Frame
    up to 30days after total mesorectal excision
    Secondary Outcome Measure Information:
    Title
    Impact on surgical operations
    Description
    The impact of CNP to operational level
    Time Frame
    Time of surgery
    Title
    Quality of surgery
    Description
    Quality of surgery determined using the mesorectal grading system
    Time Frame
    Time of surgery
    Title
    Surgery morbidity
    Description
    Surgical morbidity reported according to Clavien-Dindo classification
    Time Frame
    30 days and 12-months
    Title
    Overall survival
    Description
    Overall Survival is defined as the time from the date of surgery to the date of death
    Time Frame
    5-years
    Title
    Disease free survival
    Description
    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
    Time Frame
    5-years
    Title
    Local recurrence rate
    Description
    Local recurrence rate is defined as the time from the date of surgery to the date of the local recurrence
    Time Frame
    5-years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yingjiang Ye, MD,PhD
    Phone
    8610-88326608
    Email
    yeyingjiang@pkuph.edu.cn, yjye101@sina.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhidong Gao, MD
    Phone
    8610-88326605
    Email
    gaozhidong@pkuph.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yingjiang Ye, MD,PhD
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    We need to discuss with other centers, then decide whether to share IPD
    Citations:
    PubMed Identifier
    28881920
    Citation
    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. Erratum In: Ann Oncol. 2018 Oct 1;29(Suppl 4):iv263.
    Results Reference
    background
    PubMed Identifier
    28027520
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28078118
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25395150
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27932667
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25652878
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26252843
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24515286
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28593861
    Citation
    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. Erratum In: Lancet Oncol. 2018 Mar;19(3):e137.
    Results Reference
    background
    PubMed Identifier
    26621110
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26706785
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26310202
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23877264
    Citation
    Farinella E, Vigano L, Fava MC, Mineccia M, Bertolino F, Capussotti L. In vivo lymph node mapping and pattern of metastasis spread in locally advanced mid/low rectal cancer after neoadjuvant chemoradiotherapy. Int J Colorectal Dis. 2013 Nov;28(11):1523-9. doi: 10.1007/s00384-013-1727-4. Epub 2013 Jul 23.
    Results Reference
    background
    PubMed Identifier
    27044280
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26362137
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19638912
    Citation
    Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
    Results Reference
    background
    PubMed Identifier
    8194005
    Citation
    Mandard AM, Dalibard F, Mandard JC, Marnay J, Henry-Amar M, Petiot JF, Roussel A, Jacob JH, Segol P, Samama G, et al. Pathologic assessment of tumor regression after preoperative chemoradiotherapy of esophageal carcinoma. Clinicopathologic correlations. Cancer. 1994 Jun 1;73(11):2680-6. doi: 10.1002/1097-0142(19940601)73:113.0.co;2-c.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs