Skip to content

Prospective, randomized and multicenter study for investigation of validity of the sentinel lymph node concept in patients with cervical cancer = 2 cm

Prospective, randomized and multicenter study for investigation of validity of the sentinel lymph node concept in patients with cervical cancer = 2 cm - SENCER

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00003164
Enrollment
1200
Registered
2011-07-05
Start date
2011-09-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

cervical cancer C53.9

Interventions

Group 1: sentinel lymphadenectomy Group 2: radical pelvic lymphadenectomy

Sponsors

Charité Campus Charité Mitte
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: - Karnofsky-Index =/> 70, - 18-80 year of age - Cervical cancer diagnosed histologically - FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0 FIGO 1b1 L0 or L1 V0 = 2cm - Signed informed consent form - Patient's willing to cooperate

Exclusion criteria

Exclusion criteria: - Neuroendocrine tumours or tumours of mixed type with neuroendocrine component - Invasion of tumour cells in vascular system (V1) - Pregnancy, breast feeding - Distant metastases - Previous malignant diseases - History of pelvic radiotherapy - Severe medical disorders - Psychiatric diseases, that can interfere with participation and follow-up - HIV infection or AIDS - Drugs addiction - Existing motoric or sensoric polyneuropathy > CTC Grad 1 - impossibility to perform anesthesia

Design outcomes

Primary

MeasureTime frame
Overall survival

Secondary

MeasureTime frame
Peri- and postoperative morbidity Quality of life judged trough questionnaire EORTC QLQ C-30 (3 months after operation, then yearly till 4 year follow-up) Recurrence-free survival

Countries

Germany, Poland

Contacts

Public ContactSergio Frangini

Klinik für Gynäkologie mit Onkologie Charité Campus Mitte

sergio.frangini@charite.de030 450 664 138

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026