Is is safe to replace inguinofemoral lymphadenectomy by adjuvant radiotherapy in early stage vulvar cancer patients with a metastatic SN?
ID
Bron
Verkorte titel
Aandoening
Squamous cell carcinoma of the vulva
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Groin recurrence rate
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Is is safe to replace inguinofemoral lymphadenectomy by adjuvant radiotherapy in early stage vulvar cancer patients with a metastatic SN?
Onderzoeksopzet
7 October 2016 accrual completed, October 2018 follow-up completed
Onderzoeksproduct en/of interventie
Radiotherapy instead of inguinofemoral lymphadenectomy in patients with SN metastasis
Publiek
Maaike Oonk
Groningen 9700 RB
The Netherlands
0631623213
m.h.m.oonk@umcg.nl
Wetenschappelijk
Maaike Oonk
Groningen 9700 RB
The Netherlands
0631623213
m.h.m.oonk@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL552 |
| NTR-old | NTR608 |
| Ander register | METC Groningen : METc2005/099 |
| ISRCTN | ISRCTN37773303 |