Condition category
Cancer
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
12/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr L.E. Hamming

ORCID ID

Contact details

University Medical Center Groningen
Department of Gynecologic Oncology
CMC 5Y4218
P.O. Box 30.0010
Groningen
9700 RB
Netherlands
+31 (0)50 3613152 or 06 15504110
l.e.hamming@og.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

GROINSS-V II

Study hypothesis

It is safe to omit full inguinofemoral lymphadenectomy in vulvar cancer patients with a negative sentinel node and to replace full inguinofemoral lymphadenectomy by radiotherapy in patients with a positive sentinel node.

Please note that as of 08/02/2012 the anticipated end date for this study has been extended from 31/12/2009 to 31/01/2012.

Ethics approval

Not provided at time of registration

Study design

An observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Vulvar cancer

Intervention

Sentinel node detection, omission of full inguinofemoral lymphadenectomy in vulvar cancer patients with a negative sentinel node and to replace full inguinofemoral lymphadenectomy by radiotherapy in patients with a positive sentinel node

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Groin recurrences

Secondary outcome measures

Treatment-associated morbidity

Overall trial start date

01/12/2005

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. T1, T2 (<4 cm) primary squamous cell carcinoma of the vulva
2. Depth of invasion >1 mm
3. Not encroaching in urethra, vagina or anus with clinically negative inguinofemoral lymph nodes
4. Preoperative imaging does not show enlarged (<1.5 cm) or suspicious nodes
5. Informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

300

Participant exclusion criteria

1. Inoperable tumors and tumors with diameter >4 cm
2. Patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (>1.5 cm) or suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases
3. Patients with multifocal tumors

Recruitment start date

01/12/2005

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Medical Center Groningen (UMCG)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes