CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 78 enrolled
Drug / intervention
Cisplatin +6 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/NCT00304070
NCT00304070Phase 3Completed

Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study

Children's Oncology Group·interventional·Posted Mar 17, 2006·Updated Feb 28, 2024

In Brief

A Phase 3 clinical trial evaluating Cisplatin, Conventional Surgery, and 5 other interventions for Stage I Adrenal Cortical Carcinoma AJCC v7 and 3 related conditions. Completed, enrolled 78 participants across 91 sites in 4 countries.

Detailed Summary

This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or surgery works in treating young patients with stage I, stage II, stage III or stage IV adrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Brazil, Canada, United States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 17, 2006
Enrollment StartMay 3, 2007
Primary CompletionDec 31, 2015
Study CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 20.3 years ago

Interventions

Cisplatindrug

Given IV

Conventional Surgeryprocedure

Patients undergo surgery

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Filgrastimbiological

Given subcutaneously

Mitotanedrug

Given orally

Pegfilgrastimbiological

Given subcutaneously