Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01595061
• Date of registration: 08/05/2012
• Prospective Registration: Yes
• Primary sponsor: Gynecologic Oncology Group
• Public title: Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva
• Scientific title: 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)
• Date of first enrolment: July 2, 2012
• Target sample size: 56
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01595061
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Neil S Horowitz
• Affiliation: NRG Oncology

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Stage IIIA Vulvar Cancer AJCC v7

Stage IVA Vulvar Cancer AJCC v7

Stage IIIB Vulvar Cancer AJCC v7

Stage III Vulvar Cancer AJCC v7

Vulvar Squamous Cell Carcinoma

Stage IIIC Vulvar Cancer AJCC v7

Intervention(s)

Radiation: Intensity-Modulated Radiation Therapy

Procedure: Therapeutic Conventional Surgery

Drug: Cisplatin

Drug: Gemcitabine Hydrochloride

Primary Outcome(s)

Complete pathologic response evaluated as the frequency of complete clinical and pathologic response after primary therapy [Time Frame: 6 weeks]

Secondary Outcome(s)

Incidence and severity of adverse effects tabulated based on the Common Terminology Criterial for Adverse Events (CTCAE) v 4.0 [Time Frame: Up to 5 years]

Progression-free survival (PFS) [Time Frame: From start of protocol therapy to date of reappearance of disease or date of last contact, assessed up to 5 years]

Overall survival (OS) [Time Frame: From start of protocol therapy to death or, for living patients, the date of last contact, assessed up to 5 years]

Complete clinical response, defined as no clinical/radiographic evidence of primary disease (vulvar or groin) following chemo-radiation therapy [Time Frame: 6 weeks]

Site(s) of disease recurrence/relapse [Time Frame: Up to 5 years]

Treatment compliance, including treatment span, incidence and duration of treatment delay, reasons for delays, chemotherapy dose, radiation dose and reasons for dose level reductions [Time Frame: Up to 5 years]

Secondary ID(s)

U10CA027469

GOG-0279

NCI-2012-01964

CDR0000732793

U10CA180868

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)