CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 304 enrolled
Drug / intervention
Etoposide +4 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Histologically confirmed adrenocortical carcinoma
  • ✓Locally advanced or metastatic disease not amenable to radical surgical resection (Stage III-IV)
  • ✓Radiologically monitorable disease
  • ✓ECOG performance status 0-2
Key exclusion· 7
  • ✕Prior malignancy within 5 years (except non-melanoma skin cancer or in situ cervical carcinoma)
  • ✕Previous cytotoxic chemotherapy for adrenocortical carcinoma
  • ✕Renal insufficiency (serum creatinine ≥2 mg/dL or creatinine clearance ≤50 mL/min)
  • ✕Hepatic insufficiency (bilirubin ≥2× ULN and/or transaminases ≥3× ULN; up to 5× ULN acceptable if on mitotane)

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

Search/NCT00094497
NCT00094497Phase 3Completed
CompareCT.gov

First International Randomized Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment

Collaborative Group for Adrenocortical Carcinoma Treatment·interventional·Posted Oct 20, 2004·Updated Sep 21, 2016

In Brief

A Phase 3 clinical trial evaluating Etoposide, Doxorubicin, and 3 other interventions for Carcinoma, Adrenal Cortical. Completed, enrolled 304 participants across 32 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Adrenal Cortical
CountriesAustralia, Austria, France, Germany, Italy, Netherlands, Sweden, United States
CollaboratorsGerman Federal Ministry of Education and Research, National Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 20, 2004
Enrollment StartJun 1, 2004
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 21.7 years ago

Interventions

Etoposidedrug

Doxorubicindrug

Cisplatindrug

Streptozotocindrug

Mitotanedrug