Sentinel node biopsy in Low- and Intermediate endometrial cancer Management

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22329

Enrollment

142

Registered

2016-04-06

Start date

2016-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial cancer (early stage) Sentinel lymph node Indocyanine green

Interventions

sentinel lymph node before the operation (hysterectomie and adnexa)

Eligibility

Inclusion criteria

Inclusion criteria: Age 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 criteria

Exclusion criteria: Patients 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 Pregnancy

Design outcomes

Primary

Measure	Time frame
The proportion of patients with a positive sentinel lymph node ( at least one macro- or micrometastasis) with a change in adjuvant therapy.	—

Secondary

Measure	Time frame
1. 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.	—

Measure

Time frame

1. 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.

—

Contacts

Public ContactKarin Abbink

karin.abbink@radboudumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)