Prospectively randomized multicentric study on comparison of radical hysterectomy followed by adjuvant chemoradiation versus primary chemoradiation in patients with FIGO IB2/IIB cervical carcinoma

Prospectively randomized multicentric study on comparison of radical hysterectomy followed by adjuvant chemoradiation versus primary chemoradiation in patients with FIGO IB2/IIB cervical carcinoma - ARO zervix IB2/IIB

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004800

Enrollment

328

Registered

2013-04-22

Start date

2013-11-01

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

C53.9

Interventions

Group 1: Radical HE (Typ III oder C1 ) (open or laparoscopically -assisted or robotic-assisted or total laparoscopic) with pelvic ± para-aortic Lymphadenectomy followed by adjuvant chemo-radiation (ch

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Pts.> 18 y with SCC, Adeno- or adenosquamous carcinoma FIGO IB2 or IIB • KPS =70; • informed consent, Compliance; • no previous malignancy • no previous radiation; • no previous chemotharapy; • Kreatinin-Clearance =60 ml/h); • no anaesthesilogic contra-indications

Exclusion criteria

Exclusion criteria: • M1 except pM1 LYM; • Neuroendocrine Tumors or mixed types •previous tumors or chemo or radiation • renal insufficiency; • Psychiatric or neurologic disease with impaired compliance • HIV/ bzw. Aids, Drug Abuse •no consent regarding data transmisson no Compliance- • Pregnancy, Breast Feeding , no contraception • severe co-morbidity: (Myocardial infarction; cardiomyopathy, myocardial insifficieny NYHA III/IV, severe COPD, severe Diabetes mellitus, uncontrolled infections).

Design outcomes

Primary

Measure	Time frame
5 year Overall Survival	—

Secondary

Measure	Time frame
5 year disease free survival, 5y local control rate; Analysis of Quality of Life (EORTC QLQ – CX24, Q30), Toxicity with regard to CTCAE4.0 every 3 months for 2 years, than every 6 months, during treatment evaluation of toxicity (CTCAE4.0).	—

Countries

Germany

Contacts

Public ContactSylvia Blass

Charité

sylvia.blass@charite.de030450527112

Outcome results

None listed

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