CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Methotrexate +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02412670
NCT02412670Phase 2Completed

A Prospective Phase II Trial of Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery for Patients With High Grade Upper Tract Urothelial Carcinoma

ECOG-ACRIN Cancer Research Group·interventional·Posted Apr 9, 2015·Updated Jul 10, 2023

In Brief

A Phase 2 clinical trial evaluating Methotrexate, Vinblastine, and 6 other interventions for High Grade Upper Tract Urothelial Carcinoma. Completed, enrolled 36 participants across 134 sites.

Detailed Summary

This phase II trial studies how well giving chemotherapy before surgery works in treating patients with aggressive upper urinary tract cancer. Drugs used in chemotherapy, such as methotrexate, vinblastine, doxorubicin hydrochloride, cisplatin, gemcitabine hydrochloride, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Removing the affected upper urinary tract by surgery is the recommended treatment for upper urinary tract cancer, but can cause loss of kidney function and prevent patients from being able to receive chemotherapy after surgery. Giving chemotherapy before surgery, when the kidneys are working at their maximum, may allow less tissue to be removed during surgery and may be more effective in treating patients with high grade upper urinary tract cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 9, 2015
Enrollment StartAug 27, 2015
Primary CompletionAug 23, 2018
Study CompletionMay 10, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.2 years ago

Interventions

Methotrexatedrug

Given IV

Vinblastinedrug

Given IV

Doxorubicindrug

Given IV

Cisplatindrug

Given IV

Gemcitabinedrug

Given IV

Carboplatindrug

Given IV

Pegfilgrastimdrug

Administered subcutaneously

Nephroureterectomyprocedure

Undergo nephroureterectomy and lymph node dissection