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Chemotherapy Before Surgery in Treating Patients With High Grade Upper Urinary Tract Cancer

NCT02412670 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-07-10

Study results available
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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.

Conditions

  • High Grade Upper Tract Urothelial Carcinoma

Interventions

DRUG

Methotrexate

Given IV

DRUG

Vinblastine

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Gemcitabine

Given IV

DRUG

Carboplatin

Given IV

DRUG

Pegfilgrastim

Administered subcutaneously

PROCEDURE

Nephroureterectomy

Undergo nephroureterectomy and lymph node dissection

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • ECOG-ACRIN Cancer Research Group

    lead NETWORK

Principal Investigators

  • Vitaly Margulis · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-27
Primary Completion
2018-08-23
Completion
2022-05-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02412670 on ClinicalTrials.gov