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GROningen INternational Study on Sentinel nodes in Vulvar cancer. An observational study.


- candidate number1930
- NTR NumberNTR608
- ISRCTNISRCTN37773303
- Date ISRCTN created19-jul-2006
- date ISRCTN requested4-jul-2006
- Date Registered NTR18-jan-2006
- Secondary IDsN/A 
- Public TitleGROningen INternational Study on Sentinel nodes in Vulvar cancer. An observational study.
- Scientific TitleGROningen INternational Study on Sentinel nodes in Vulvar cancer. An observational study.
- ACRONYMGROINSS-V II
- hypothesisIt 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.
- Healt Condition(s) or Problem(s) studiedVulvar cancer
- Inclusion criteria1. T1, T2 (< 4 cm) primary squamous cell carcinoma of the vulva; 2. Depth of invasion > 1mm; 3. Not encroaching in urethra, vagina or anus with clinically negative inguinofemoral lymph nodes; 4. Preoperative imaging does not show enlarged (< 1.5 cm) / suspicious nodes; 5. Possibility to obtain informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-dec-2005
- planned closingdate1-dec-2009
- Target number of participants300
- InterventionsSentinel 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.
- Primary outcomeGroin recurrences.
- Secondary outcomeTreatment associated morbidity.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L.E. Hamming
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.G.J. Zee, van der
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryIt is likely that cancer of the vulva does not spread to lots of glands at once, but instead each cancer may spread to just one or two glands first, before moving on to affect others. These first glands are called the ‘sentinel nodes’. Evidence from initial studies suggests that just by examining the sentinel nodes, we can tell whether the rest of the glands in the groin are free from cancer. This operation (sentinel node dissection) is much smaller than the usual operation of removing all the glands from the groin and it is likely that it will have fewer complications. However, before we can offer it to all patients as the first choice operation, we need to collect further evidence to ensure that it is as effective as the traditional operation for this disease. Sentinel node dissection is already in use for other cancers eg. breast and some skin cancers. In this study we will investigate whether it is safe to omit the removal of all glands from the groin(s) when the sentinel gland is free of cancer, and also whether it is safe to immediately irradiate the groin(s) when the sentinel gland does contain cancer cells, instead of operating the groin(s) and removing all the remaining nodes, eventually followed by irradiation.
- Main changes (audit trail)
- RECORD18-jan-2006 - 12-nov-2008


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