Clinical trial · Interventional
Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy
Prospective Randomized Clinical Trial of Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy
NCT03550001CI-TRIAL-00033263CALOR-NATunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection CNP before NAT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Injection CNP before NAT
- description
- Inject carbon nanoparticle as a lymph node tracer before the patient receive neoadjuvant therapy.
- interventionNames
- Procedure: Injection CNP before NAT
- type
- NO_INTERVENTION
- label
- No injection
- description
- Do not inject carbon nanoparticle during the treatment.
Primary outcomes (1)
- measure
- lymph node yield
- timeFrame
- up to 30days after total mesorectal excision
- description
- Amount of lymph node yield, dyeing lymph node, positive lymph node and the dyeing positive lymph node
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (17)
- BACKGROUNDGlynne-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
- BACKGROUNDMechera 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
- BACKGROUNDGurawalia 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
- BACKGROUNDKim 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
- BACKGROUNDXu 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
- BACKGROUNDLykke 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