Phase 2
N=61
Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva
Stage III Vulvar Cancer · Stage IVB Vulvar Cancer · Vulvar Squamous Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00068406 ↗Enrolled (actual)
61
Serious AEs
29.3%
Results posted
Oct 2017
Primary outcome: Primary: Complete Clinical and Pathologic Response — 50 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3-Dimensional Conformal Radiation Therapy (Radiation); Cisplatin (Drug); Conventional Surgery (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Clinical and Pathologic Response |
50 | — |
| PRIMARY Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period |
18; 4; 3; 11; 13; 5 | — |
Summary
This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva. Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery.
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
Data sourced from ClinicalTrials.gov (NCT00068406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.