Clinical trial · Interventional
Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva
A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva (NCT #01595061)
- 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)
This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIIA Vulvar Cancer AJCC v7 | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Vulvar Cancer AJCC v7 | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Vulvar Cancer AJCC v7 | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Vulvar Cancer AJCC v7 | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Vulvar Cancer AJCC v7 | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Vulvar Squamous Cell Carcinoma | Vulvar Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (IMRT, gemcitabine, cisplatin, surgery)
- description
- Patients undergo IMRT 5 days a week for 6 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to confirm response or surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes.
- interventionNames
- Drug: Cisplatin
- Drug: Gemcitabine Hydrochloride
- Radiation: Intensity-Modulated Radiation Therapy
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (1)
- measure
- Complete Pathologic Response
- timeFrame
- 6 -8 weeks after completion of chemo-radiation
- description
- Percentage of participants with complete pathologic response. Complete pathologic response is defined as negative local core biopsy or FNA specimens following primary chemo-radiation therapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with locally advanced, previously untreated squamous cell carcinoma of the vulva * Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy * Absolute neutrophil count (ANC) \>= 1,500/mcl * Platelets \>= 100,000/mcl * Creatinine =\< 1.5 times institutional upper limit of normal (ULN) OR calculated creatinine clearance \>= 60 mL/min * Bilirubin =\< 1.5 x ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 x ULN * Alkaline phosphatase =\< 3 x ULN * Patients judged capable of tolerating a radical course of chemoradiation therapy * Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients with a GOG performance status of 0, 1, or 2 Exclusion Criteria: * Patients with recurrent carcinoma of the vulva regardless of previous treatment * Patients who have received prior pelvic radiation or cytotoxic chemotherapy * Patients with vulvar melanomas or sarcomas * Patients with circumstances that will not permit completion of the study or the required follow-up * Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
References
Publications (1)
- DERIVEDHorowitz NS, Deng W, Peterson I, Mannel RS, Thompson S, Lokich E, Myers T, Hanjani P, O'Malley DM, Chung KY, Miller DS, Ueland FR, Dizon DS, Miller A, Mayadev JS, Leath CA 3rd, Monk BJ. Phase II Trial of Cisplatin, Gemcitabine, and Intensity-Modulated Radiation Therapy for Locally Advanced Vulvar Squamous Cell Carcinoma: NRG Oncology/GOG Study 279. J Clin Oncol. 2024 Jun 1;42(16):1914-1921. doi: 10.1200/JCO.23.02235. Epub 2024 Apr 4. PMID 38574312