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Rectal CancerCALOR-NATNCT03550001

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

A study testing Injection CNP before NAT in people with Rectal Cancer, run by YE Yingjiang.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Cancer
What is being tested?
Injection CNP before NAT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
No sites listed yet
Study dates
1 Jun 2018to 1 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Yingjiang Ye, MD,PhD contact

8610-88326608

yeyingjiang@pkuph.edu.cn, yjye101@sina.com

Zhidong Gao, MD contact

8610-88326605

gaozhidong@pkuph.edu.cn

About this study

Official title: 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.

Read the 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.

Conditions
Rectal Cancer
Being tested
Injection CNP before NAT
Keywords
locally advanced rectal cancer, lymph node yeild, lymph node tracer, stage shift, prognosis
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injection CNP before NATProcedure or surgery

    Injection carbon nanoparticle via rectal mucosa before neoadjuvant therapy

Study groups in NCT03550001
Study groupRoleWhat they receive
Injection CNP before NATExperimentalInject carbon nanoparticle as a lymph node tracer before the patient receive neoadjuvant therapy.
Receives: Procedure: Injection CNP before NAT
No injectionNo interventionDo not inject carbon nanoparticle during the treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. lymph node yield

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

    Measured: up to 30days after total mesorectal excision

Secondary outcomes (6)

  1. Impact on surgical operations

    The impact of CNP to operational level

    Measured: Time of surgery

  2. Quality of surgery

    Quality of surgery determined using the mesorectal grading system

    Measured: Time of surgery

  3. Surgery morbidity

    Surgical morbidity reported according to Clavien-Dindo classification

    Measured: 30 days and 12-months

  4. Overall survival

    Overall Survival is defined as the time from the date of surgery to the date of death

    Measured: 5-years

  5. 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

    Measured: 5-years

  6. Local recurrence rate

    Local recurrence rate is defined as the time from the date of surgery to the date of the local recurrence

    Measured: 5-years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2018
  2. Study start1 Jun 2018 (estimated)
  3. Primary completion1 Jun 2019 (estimated)
  4. Study completion1 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel
Masking
None (open label)
Enrolment
252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03550001
Sponsor's protocol ID
2017-PKUPH077
Acronym
CALOR-NAT
Status last verified
May 2018
First submitted
25 May 2018
Last updated
8 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We need to discuss with other centers, then decide whether to share IPD

Publications

  • 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.

    PubMed 28881920

  • 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.

    PubMed 28027520

  • 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.

    PubMed 28078118

  • 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.

    PubMed 25395150

  • 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.

    PubMed 27932667

  • 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.

    PubMed 25652878

  • 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.

    PubMed 26252843

  • 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.

    PubMed 24515286

  • 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.

    PubMed 28593861

  • 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.

    PubMed 26621110

  • 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.

    PubMed 26706785

  • 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.

    PubMed 26310202

  • 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.

    PubMed 23877264

  • 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.

    PubMed 27044280

  • 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.

    PubMed 26362137

Questions about this trial

What is this clinical trial studying?

A study testing Injection CNP before NAT in people with Rectal Cancer, run by YE Yingjiang.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yingjiang Ye, MD,PhD (8610-88326608, yeyingjiang@pkuph.edu.cn, yjye101@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

lymph node yield (time frame: up to 30days after total mesorectal excision). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03550001, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.

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