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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

Pivotal Trial

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year or while on protocol therapy, whichever is less

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Five Year Event-free Survival (EFS)

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860

Mitotane

2022

Completed Phase 3

~430