Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
NCT ID:
NCT00068406
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of locally advanced squamous cell carcinoma of the vulva
* T3 or T4 (N0-3, M0)
* Not amenable to surgical resection by standard radical vulvectomy
* Previously untreated disease
* No recurrent disease
* No vulvar melanoma or sarcoma
* Performance status - GOG 0-3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times normal
* Alkaline phosphatase no greater than 3 times normal
* SGOT no greater than 3 times normal
* Creatinine no greater than 2.0 mg/dL
* No gastrointestinal bleeding
* No severe gastrointestinal symptoms
* Capable of tolerating a radical course of chemoradiotherapy
* No septicemia
* No severe infection
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No circumstance that would preclude study completion or follow-up
* No prior cytotoxic chemotherapy
* No prior pelvic radiotherapy
* No concurrent boost brachytherapy
* No prior anticancer therapy that would contraindicate study therapy
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00068406
Study Brief:
Protocol Section:
NCT00068406