Clinical trial · Interventional
Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva
Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva
NCT00003325CI-TRIAL-00018075completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva. PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel lymph node mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Sentinenal lymph node mapping
- description
- Sentinenal lymph node mapping
- interventionNames
- Procedure: Sentinel lymph node mapping
Primary outcomes (1)
- measure
- Predictive value of negative sentinel lymph nodes in vulvar cancer patients
- timeFrame
- at time of surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed invasive squamous cell carcinoma of the vulva that is greater than 1 mm in thickness as measured from the nearest rete peg * Tumor size must be 2-6 cm * No recurrent disease * Prior excision of the primary disease or a history of carcinoma in situ of the vulva allowed * No tumor extending into the urethra, anus, vagina, rectum, or bladder * No grossly suspicious or inflamed groin nodes on physical exam * No grossly infected primary tumors PATIENT CHARACTERISTICS: Age: * Any age Performance status: * GOG 0-3 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other invasive malignancy within the past 5 years except non-melanomatous skin cancer * No known hypersensitivity to phenylethane compounds PRIOR CONCURRENT THERAPY: * No prior cancer therapy that contraindicates therapy in this study Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics * No prior groin dissection
References
Publications (2)
- RESULTLevenback CF, Ali S, Coleman RL, Gold MA, Fowler JM, Judson PL, Bell MC, De Geest K, Spirtos NM, Potkul RK, Leitao MM Jr, Bakkum-Gamez JN, Rossi EC, Lentz SS, Burke JJ 2nd, Van Le L, Trimble CL. Lymphatic mapping and sentinel lymph node biopsy in women with squamous cell carcinoma of the vulva: a gynecologic oncology group study. J Clin Oncol. 2012 Nov 1;30(31):3786-91. doi: 10.1200/JCO.2011.41.2528. Epub 2012 Jul 2. PMID 22753905
- RESULTLevenback CF, Tian C, Coleman RL, et al.: Sentinel node (SN) biopsy in patients with vulvar cancer: A Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 27 (Suppl 15): A-5505, 2009.