conventional surgery for Carcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Carcinoma+6 More
conventional surgery - Procedure
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Carcinoma
  • Adrenocortical carcinoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to one year or while on protocol therapy, whichever is less

At study enrollment
Frequency of Lymph Node Involvement by Imaging.
Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis.
Patients who had surgery at time of enrollment.
Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.
Month 1
Complications Associated With Radical Adrenalectomy and RLND
Day 182
Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Up to five years after enrollment
Five Year Event-free Survival (EFS)
Up to one year or while on protocol therapy, whichever is less
Frequency of Tumor Spillage at the Time of Tumor Resection

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Stratum III (chemotherapy, surgery)
1 of 3
Stratum II (exploratory surgery, observation)
1 of 3
Stratum I (surgery, observation)
1 of 3
Experimental Treatment

78 Total Participants · 3 Treatment Groups

Primary Treatment: conventional surgery · No Placebo Group · Phase 3

Stratum III (chemotherapy, surgery)Experimental Group · 6 Interventions: filgrastim, doxorubicin hydrochloride, etoposide, cisplatin, conventional surgery, mitotane · Intervention Types: Biological, Drug, Drug, Drug, Procedure, Drug
Stratum II (exploratory surgery, observation)
Procedure
Experimental Group · 1 Intervention: conventional surgery · Intervention Types: Procedure
Stratum I (surgery, observation)
Procedure
Experimental Group · 1 Intervention: conventional surgery · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
FDA approved
Doxorubicin
FDA approved
Etoposide
FDA approved
Cisplatin
FDA approved
conventional surgery
1994
Completed Phase 3
~13900

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to one year or while on protocol therapy, whichever is less

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,810 Total Patients Enrolled
1,306 Trials studying Carcinoma
389,677 Patients Enrolled for Carcinoma
Children's Oncology GroupLead Sponsor
446 Previous Clinical Trials
235,012 Total Patients Enrolled
9 Trials studying Carcinoma
12,399 Patients Enrolled for Carcinoma
Carlos Rodriguez-GalindoPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
131 Total Patients Enrolled
2 Trials studying Carcinoma
131 Patients Enrolled for Carcinoma

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a blood glucose level of at least 0.6 mg/dL (1 to < 2 years of age).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.