No registrations found.
ID
Source
Brief title
Health condition
Squamous cell carcinoma of the vulva
Sponsors and support
Intervention
Outcome measures
Primary outcome
Groin recurrence rate
Secondary outcome
Treatment associated morbidity.
Background summary
The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V) II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). It was a prospective multicentre phase 2 treatment trial, including patients with early-stage squamous cell carcinoma (SCC) of the vulva (diameter <4cm) without signs of lymph node involvement at imaging, who had primary surgical treatment with SN-biopsy. Where the SN was positive for disease (metastasis of any size), radiotherapy was given to the inguinofemoral region (50Gy). Stopping rules were defined for the occurrence of groin recurrences.
Study objective
Is is safe to replace inguinofemoral lymphadenectomy by adjuvant radiotherapy in early stage vulvar cancer patients with a metastatic SN?
Study design
7 October 2016 accrual completed, October 2018 follow-up completed
Intervention
Radiotherapy instead of inguinofemoral lymphadenectomy in patients with SN metastasis
Maaike Oonk
Groningen 9700 RB
The Netherlands
0631623213
m.h.m.oonk@umcg.nl
Maaike Oonk
Groningen 9700 RB
The Netherlands
0631623213
m.h.m.oonk@umcg.nl
Inclusion criteria
1. Primary squamous cell carcinoma of the vulva < 4cm
2. Depth of invasion > 1mm;
3. Not encroaching in urethra, vagina or anus, and clinically negative inguinofemoral lymph nodes;
4. Preoperative imaging does not show enlarged (< 1.5 cm) / suspicious nodes;
5. Possibility to obtain informed consent.
Exclusion criteria
1. Inoperable tumors and tumors with diameter > 4cm;
2. Patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (>1.5 cm) / suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases;
3. Patients with multifocal tumors.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL552 |
| NTR-old | NTR608 |
| Other | METC Groningen : METc2005/099 |
| ISRCTN | ISRCTN37773303 |