CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
Cisplatin +2 moredrug
Likely dose
Cisplatin given IV weekly with concurrent 3-dimensional conformal radiation therapyAI-extracted
Key inclusion· 5
  • Diagnosis of locally advanced squamous cell carcinoma of the vulva, T3 or T4 stage (N0-3, M0)
  • Disease not amenable to surgical resection by standard radical vulvectomy
  • Previously untreated disease with no recurrent disease
  • GOG performance status 0–3
Key exclusion· 6
  • Vulvar melanoma or sarcoma
  • Gastrointestinal bleeding or severe gastrointestinal symptoms
  • Septicemia or severe infection
  • Other invasive malignancy within the past 5 years (except nonmelanoma skin cancer)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00068406
NCT00068406Phase 2Completed

A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva

Gynecologic Oncology Group·interventional·Posted Sep 11, 2003·Updated Nov 20, 2017

In Brief

A Phase 2 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Cisplatin, and 1 other intervention for Stage III Vulvar Cancer and 2 related conditions. Completed, enrolled 61 participants across 103 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2003
Enrollment StartJan 1, 2005
Primary CompletionDec 1, 2010
Study CompletionJan 20, 2012
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 22.8 years ago

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Cisplatindrug

Given IV

Conventional Surgeryprocedure