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Alkylating agents

Intensity-Modulated Radiation Therapy for Vulvar Cancer

Phase 2
Waitlist Available
Led By Neil S Horowitz
Research Sponsored by Gynecologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study entry to disease progression, death or date of last contact, whichever occurs first. the median for observed pfs was 26.2 month with a range from 1.5 months to 82.4 months
Awards & highlights

Study Summary

This trial is studying how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin for squamous cell cancer of the vulva.

Eligible Conditions
  • Vulvar Cancer
  • Vulvar Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study entry to disease progression, death or date of last contact, whichever occurs first. the median for observed pfs was 26.2 month with a range from 1.5 months to 82.4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study entry to disease progression, death or date of last contact, whichever occurs first. the median for observed pfs was 26.2 month with a range from 1.5 months to 82.4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Pathologic Response
Secondary outcome measures
Adverse Events (Grade 3 or Higher) During Treatment Period
Complete Clinical Response
Progression-free Survival (PFS)

Side effects data

From 2013 Phase 3 trial • 637 Patients • NCT00884741
30%
Fatigue
20%
Thrombosis
20%
Nausea
20%
Hemoglobin decreased
20%
Lymphopenia
20%
Alanine aminotransferase increased
20%
Hyperglycemia
20%
Hyponatremia
20%
Seizure
10%
Alopecia
10%
Weight loss
10%
Opportunistic infection
10%
Dry mouth
10%
Wound infection [with normal or Grade 1-2 ANC]
10%
Wound infection [with unknown ANC]
10%
Wound dehiscence
10%
Vascular access complication
10%
Dysphagia
10%
Acoustic nerve disorder NOS
10%
Anorexia
10%
Dehydration
10%
Eye disorder
10%
Disease progression
10%
Headache
10%
Hearing loss
10%
Tinnitus
10%
Fracture
10%
Creatinine increased
10%
Hyperkalemia
10%
Hypermagnesemia
10%
Hypoalbuminemia
10%
Muscle weakness left-sided
10%
Memory impairment
10%
Neurological disorder NOS
10%
Taste alteration
10%
Depression
10%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pre-Randomization TMZ+RT
Randomized Arm 1: TMZ+RT + Placebo
Randomized Arm 2: TMZ+RT + Bevacizumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (IMRT, gemcitabine, cisplatin, surgery)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,610 Total Patients Enrolled
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,869 Total Patients Enrolled
Neil S HorowitzPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva
2012. "Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01595061.
~4 spots leftby Apr 2025
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