NCT01500512 (GROINSS-V) is a clinical trial of Clinical Observation in Stage I Vulvar Cancer, sponsored by Gynecologic Oncology Group.

Who is sponsoring NCT01500512?

NCT01500512 is sponsored by Gynecologic Oncology Group.

What drugs are being tested in NCT01500512?

Interventions in NCT01500512: Clinical Observation.

What condition does NCT01500512 study?

NCT01500512 studies Stage I Vulvar Cancer, Stage II Vulvar Cancer, Stage III Vulvar Cancer, Vulvar Squamous Cell Carcinoma.

Is NCT01500512 still recruiting?

NCT01500512 is currently status unknown. Last updated 30 September 2021.

Last reviewed 2021-09-30 · How we verify

NCT01500512: GROINSS-V

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection

Status unknown Last updated 30 September 2021

What this trial tests

trial testing Clinical Observation in Stage I Vulvar Cancer in 148 participants. Status unknown.

Timeline

3 January 2012

Primary endpoint
1 July 2022

Quick facts

Lead sponsor	Gynecologic Oncology Group
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	148
Start date	3 January 2012
Primary completion	1 July 2022
Sites	37 locations across Canada, United States

Drugs / interventions tested

Clinical Observation

Conditions studied

Stage I Vulvar Cancer — all drugs for Stage I Vulvar Cancer →
Stage II Vulvar Cancer — all drugs for Stage II Vulvar Cancer →
Stage III Vulvar Cancer — all drugs for Stage III Vulvar Cancer →
Vulvar Squamous Cell Carcinoma — all drugs for Vulvar Squamous Cell Carcinoma →

Sponsor

Gynecologic Oncology Group — full company profile →

Who can join

18 and older, female only, with Stage I Vulvar Cancer or Stage II Vulvar Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph node dissection. Sentinel lymph node dissection may have fewer side effects than removing all lymph nodes. Observing patients undergoing sentinel lymph node dissection may help doctors confirm the safety of the procedure.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Is bilateral lymphadenectomy for midline squamous carcinoma of the vulva always necessary? An analysis from Gynecologic Oncology Group (GOG) 173.
Coleman RL, Ali S, Levenback CF, Gold MA, et al · · 2013 · cited 48× · PMID 23201592 · DOI 10.1016/j.ygyno.2012.11.034
Management of Early-Stage Vulvar Cancer.
Pedrão PG, Guimarães YM, Godoy LR, Possati-Resende JC, et al · · 2022 · cited 23× · PMID 36077719 · DOI 10.3390/cancers14174184
The efficacy of ultrasound in the follow up after a negative sentinel lymph node in women with vulvar cancer: a prospective single-centre study.
Pouwer AW, Mus R, IntHout J, van der Zee A, et al · · 2018 · cited 14× · PMID 29924914 · DOI 10.1111/1471-0528.15341
Clinical trials in gynecologic oncology: Past, present, and future.
Annunziata CM, Kohn EC. · · 2018 · cited 8× · PMID 29212614 · DOI 10.1016/j.ygyno.2017.11.026

Verify or expand the search:

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Other Gynecologic Oncology Group trials

Trials by the same sponsor.

NCT04393285 — Abemaciclib and Letrozole to Treat Endometrial Cancer · Phase 2 · active not recruiting
NCT03673124 — Ribociclib and Letrozole Treatment in Ovarian Cancer · Phase 2 · active not recruiting
NCT02065687 — Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent · Phase 2, PHASE3 · unknown
NCT01720173 — Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer · Phase 2 · completed
NCT01406769 — Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stag · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01500512 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gynecologic Oncology Group
Last refreshed: 30 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01500512.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing