Prospective randomized controlled trial to compare operative methods in early-stage cervical cancer

Prospective randomized controlled trial to compare operative methods in early-stage cervical cancer - SIMRA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006068

Enrollment

200

Registered

2014-07-02

Start date

2014-06-17

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

C53

Interventions

Group 1: Simple Conization Group 2: Radical Vaginal Trachelectomy

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Patients with cervical cancer, Squamous Cell Carcinoma and Adenocarcinoma Cervical Cancer FIGO I (=pT1a1 L1, to Ib1 < 2cm) Desire to have children Possibility to obtain informed consent

Exclusion criteria

Exclusion criteria: Patients with multifocal tumours Neuroendocrinological carcinoma / tumours Invasion of small vessels (V1) Pregnancy History of other malignancies

Design outcomes

Primary

Measure	Time frame
Rates of Preterm Delivery Follow-ups every 3 months postoperative for 2 years, after that every 6 months overall 5 years	—

Secondary

Measure	Time frame
Disease-free Survival Peri- and Postoperative Complication Rates Quality of Life Overall survival Marker of recurrence Follow-ups every 3 months postoperative for 2 years, after that every 6 months overall 5 years	—

Countries

Germany

Contacts

Public ContactAnne Bartens

Klinik für GynäkologieCharité Campus Charité Mitte

gynstudien-ccm@charite.de030 450 564172

Outcome results

None listed

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