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van CCT (UK)

van CCT (UK)

Sentinel node biopsy in Low- and Intermediate endometrial cancer Management

- candidate number24197
- NTR NumberNTR5794
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2016
- Secondary IDsNL49827-091.14 
- Public TitleSentinel node biopsy in Low- and Intermediate endometrial cancer Management
- Scientific TitleSentinel node biopsy in Low- and Intermediate endometrial cancer Management
- hypothesisThe proportion of patients with a positive sentinel lymph node( at least one macro- or micrometastasis) which alter the adjuvant therapy
- Healt Condition(s) or Problem(s) studiedEndometrial carcinoma, Sentinel Lymph Node Biopsy (SLNB)
- Inclusion criteriaAge 18 years
Histological confirmed endometrioid adenocarcinoma of the endometrium grade 1 or 2 on microcurettage
Low-risk: type 1 endometrial cancer, stage IA grade 1 or 2 or Intermediate-risk: type 1 endometrial cancer, stage IB grade 1 or 2
WHO-performance 0-2
WBC > 3.0x 109/L, platelets > 100 x 109/L, creatinine clearance > 60ml/min
CT-scan with no evidence of distant metastases
- Exclusion criteriaPatients with high-risk type 1 endometrial cancer stage (IB grade 3) or type 2 endometrial cancer (defined as > 10% of the specimen is serous or clear cell type) of any grade and stage.
Patients with intermediate- risk stage IA grade 3 type 1 endometrial cancer
Patients with contraindications to surgery, anesthesia or pelvic radiation.
Patients with an allergic reaction on Technetium 99m-Nanocolloid, ICG or patent-blue
Patients with previous pelvic or para-aortic lymph node dissection or sampling for a previous malignancy
Previous pelvic or abdominal radiotherapy
Patients with evidence of pelvic and/or distant metastasis
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-mrt-2016
- planned closingdate1-mrt-2019
- Target number of participants142
- Interventionssentinel lymph node before the operation (hysterectomie and adnexa)
- Primary outcomeThe proportion of patients with a positive sentinel lymph node ( at least one macro- or micrometastasis) with a change in adjuvant therapy.
- Secondary outcome1. To evaluate the incidence of ITC, micro- and macrometastases
2. To assess the detection rate of the SLN biopsy in one and two pelvic hemisphere
3. To investigate if SLN biopsy in women with low- and intermediate-risk endometrial cancer will lead to better disease free and overall survival
4. To assess if the presence of only ITC leads to more recurrences of disease
5. To investigate the risks and complications of the SLN biopsy.
- TimepointsHistological evaluation of the sentinel lymph node with ultrastaging and immunohystochemistry after surgery.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Center Nijmegen
- Publications2020
- Brief summaryThe treatment of endometrial cancer (EC) is primarily surgery (removal of uterus and adnexa). There is an ongoing controversy in the management of EC relates to lymphadenectomy. Randomized trials and a meta-analysis have shown that pelvic lymphadenectomy has no effect on overall or recurrence-free survival, but can lead to longer operation time and morbidity [Kitchener et al. 2009, Benedetti et al. 2008, May et al. Cochrane Rev 2010] However, the trials on lymphadenectomy in early stage endometrial cancer did not take into account the contribution of sentinel lymph node (SLN) biopsy in reducing the risk of surgical complications and improving staging.
Recent studies showed that SLN biopsy with ultra-staging upstaged 10% of patients with presumed low-risk and 15% of patients with presumed intermediate risk [Ballister et al. 2008, 2011;Abu Rustum 2014]. As involvement of lymph nodes has been proven to be one of the most important prognostic factors in other malignant tumors, SLN biopsy might be a good compromise between systemic lymph node dissection and no node dissection in women with low- or intermediate-risk EC.
When the lymph node status is unknown, indications for adjuvant therapies are on pathological features of surgical specimen of the primary tumor, exposing some patients to overtreatment and undertreatment. Introducing SNP in the treatment of EC will lead to only giving adjuvant treatment when women are truly at risk.
SLN biopsy in EC can be performed with cervical injection prior to surgery using indocyanine green with high detection rates 92-96% and negative predictive values 98-99%.
- Main changes (audit trail)
- RECORD6-apr-2016 - 29-mei-2016

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