Vulvar field resection trial

Vulvar field resection trial - VFR

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013358

Enrollment

500

Registered

2017-11-27

Start date

2009-07-28

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

C51

Interventions

Group 1: All successive patients with vulvar cancer stages oT1-3b admitted to one of the study centers and meeting the inclusion criteria are candidates for the VFR-trial. Surgical tumor excision in

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Vulvar carcinoma staged oT1-oT3b, Provision of written informed consent to participate in the trial

Exclusion criteria

Exclusion criteria: Compromised general condition (Karnovsky index <80), Comorbidity which is not compatible with the operation, Distant metastases

Design outcomes

Primary

Measure	Time frame
Evaluation of complications and sequelae of treatment according to the Clavien-Dindo-Classification during the immediate post-operative period and 3 months postoperatively. This includes photographic documentation of the reconstructive results. Thereafter, patients are regularly followed up by their gynecologists. Recurrence-free and disease-specific survival are assessed by contacting all study participants or their gynecologists at regular interval. If no information on the survival status of the patient is available, the national or regional cancer registries are contacted for further information. The follow-up period is not limited.	—

Measure

Time frame

Evaluation of complications and sequelae of treatment according to the Clavien-Dindo-Classification during the immediate post-operative period and 3 months postoperatively. This includes photographic documentation of the reconstructive results. Thereafter, patients are regularly followed up by their gynecologists. Recurrence-free and disease-specific survival are assessed by contacting all study participants or their gynecologists at regular interval. If no information on the survival status of the patient is available, the national or regional cancer registries are contacted for further information. The follow-up period is not limited.

—

Secondary

Measure	Time frame
Histopathological tumor assessment with regard to ontogenetic anatomy is performed post-operatively. Quality of life and psychological sequelae of VFR are assessed 3 and 12 months postoperatively using the EORTC-QOL-30 (general quality of life assessment in cancer patients). The presence of lymph edema is assessed at the specified time points using the gynecologic cancer lymph edema questionnaire (GCLQ). Overall survival is assessed analogous to recurrence-free and disease-specific survival as outlined above.	—

Measure

Time frame

Histopathological tumor assessment with regard to ontogenetic anatomy is performed post-operatively. Quality of life and psychological sequelae of VFR are assessed 3 and 12 months postoperatively using the EORTC-QOL-30 (general quality of life assessment in cancer patients). The presence of lymph edema is assessed at the specified time points using the gynecologic cancer lymph edema questionnaire (GCLQ). Overall survival is assessed analogous to recurrence-free and disease-specific survival as outlined above.

—

Countries

Germany

Contacts

Public ContactFabinshy ;Benjamin Thangarajah;Wolf

Universitätsfrauenklinik Essen;Universitätsfrauenklinik Leipzig

fabinshy.thangarajah@uk-essen.de;benjamin.wolf@medizin.uni-leipzig.de+49 (0) 201 72385288;0341-9723400

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 7, 2026