GROningen INternational Study on Sentinel nodes in Vulvar cancer. An observational study.
| ISRCTN | ISRCTN37773303 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37773303 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/07/2006
- Registration date
- 19/07/2006
- Last edited
- 12/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr L.E. Hamming
Scientific
Scientific
University Medical Center Groningen
Department of Gynecologic Oncology
CMC 5Y4218
P.O. Box 30.0010
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3613152 or 06 15504110 |
|---|---|
| l.e.hamming@og.umcg.nl |
Study information
| Study design | An observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | GROINSS-V II |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Groin recurrences |
| Secondary outcome measures | Treatment-associated morbidity |
| Overall study start date | 01/12/2005 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 300 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
University/education
University/education
P.O. Box 30001
Groningen
9700 RB
Netherlands
"ROR" |
https://ror.org/03cv38k47 |
|---|
Funders
Funder type
University/education
University Medical Center Groningen (UMCG)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
