← Back to Search

Alkylating agents

Stratum I (surgery, observation) for Adrenal Carcinoma

Phase 3
Waitlist Available
Led By Carlos Rodriguez-Galindo
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year or while on protocol therapy, whichever is less
Awards & highlights

Study Summary

This trial is studying how well cisplatin-based chemotherapy and/or surgery works in treating young patients with adrenocortical cancer.

Eligible Conditions
  • Adrenal Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year or while on protocol therapy, whichever is less
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year or while on protocol therapy, whichever is less for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Five Year Event-free Survival (EFS)
Secondary outcome measures
Complications Associated With Radical Adrenalectomy and RLND
Frequency of Lymph Node Involvement by Imaging.
Frequency of Tumor Spillage at the Time of Tumor Resection
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Stratum III (chemotherapy, surgery)Experimental Treatment7 Interventions
Patients receive combination chemotherapy with filgrastim (G-CSF) for up to 30 weeks (10 courses) followed by mitotane alone for an additional 2 months. Some patients undergo surgery after chemotherapy course 2 or 4. Some patients undergo additional surgery after finishing all chemotherapy.
Group II: Stratum II (exploratory surgery, observation)Experimental Treatment1 Intervention
Patients undergo primary tumor resection and extended regional lymph node dissection followed by observation. Patients who have undergone prior surgery with simple resection of the primary tumor undergo exploratory surgery with extended regional lymph node dissection followed by observation.
Group III: Stratum I (surgery, observation)Experimental Treatment1 Intervention
Patients undergo primary tumor resection and retroperitoneal lymph node sampling followed by observation. Patients who have undergone prior surgery without nodal sampling undergo observation only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Filgrastim
2000
Completed Phase 3
~3670
Mitotane
2022
Completed Phase 3
~420
Pegfilgrastim
2013
Completed Phase 3
~4440
Etoposide
2010
Completed Phase 3
~2440
Conventional Surgery
2006
Completed Phase 3
~1080

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,964,980 Total Patients Enrolled
Children's Oncology GroupLead Sponsor
456 Previous Clinical Trials
239,708 Total Patients Enrolled
Carlos Rodriguez-GalindoPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
131 Total Patients Enrolled
~4 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top