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Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)

NCT00094497 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2016-09-21

Study results available
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Summary

The purpose of this study is to determine whether treatment with etoposide, doxorubicin, cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane (Sz/M) in patients with advanced adrenocortical carcinoma (ACC) whose disease is not amenable to complete surgical resection.

Conditions

  • Carcinoma, Adrenal Cortical

Interventions

DRUG

Etoposide

DRUG

Doxorubicin

DRUG

Cisplatin

DRUG

Streptozotocin

DRUG

Mitotane

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • National Cancer Institute (NCI)

    collaborator NIH

  • Collaborative Group for Adrenocortical Carcinoma Treatment

    lead OTHER

Principal Investigators

  • Britt Skogseid, MD · Uppsala University Hospital

  • Martin Fassnacht, MD · University of Würzburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States
  • Australia
  • Austria
  • France
  • Germany
  • Italy
  • Netherlands
  • Sweden

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 NCT00094497 on ClinicalTrials.gov