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Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor

NCT00304070 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-02-28

Study results available
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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.

Conditions

  • Stage I Adrenal Cortical Carcinoma AJCC v7
  • Stage II Adrenal Cortical Carcinoma AJCC v7
  • Stage III Adrenal Cortical Carcinoma AJCC v7
  • Stage IV Adrenal Cortical Carcinoma AJCC v7

Interventions

DRUG

Cisplatin

Given IV

PROCEDURE

Conventional Surgery

Patients undergo surgery

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given subcutaneously

DRUG

Mitotane

Given orally

BIOLOGICAL

Pegfilgrastim

Given subcutaneously

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Carlos Rodriguez-Galindo · Children's Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-03
Primary Completion
2015-12-31
Completion
2023-06-30

Countries

  • United States
  • Australia
  • Brazil
  • Canada

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 NCT00304070 on ClinicalTrials.gov