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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

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
~4410
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
13,658 Previous Clinical Trials
40,924,563 Total Patients Enrolled
Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
237,862 Total Patients Enrolled
Carlos Rodriguez-GalindoPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
131 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many hospitals are participating in this study?

"Presently, this clinical trial is taking place in 77 different medical facilities. These locations include major cities such as Montreal, Halifax, and Dallas. If it is possible, patients should select the trial site that is closest to them in order to reduce travel time and expenses."

Answered by AI

For what medical conditions is surgery the go-to treatment?

"Conventional surgery is the go-to treatment for most patients with merkel cell cancer. However, it can also prove effective in managing other conditions, such as prostate cancer, advanced testicular cancer, and small cell lung cancer."

Answered by AI

Does this approach to surgery have a long and storied tradition?

"The first clinical trial examining the efficacy of conventional surgery was conducted in 1997 at Spectrum Health Hospital - Butterworth Campus. As of now, a total of 2,195 studies have completed. There are 1,305 active clinical trials at the moment, with many of these taking place in Montreal, Quebec."

Answered by AI

Has the FDA cleared traditional surgery as an effective treatment?

"While there is some data supporting the efficacy of conventional surgery, it has undergone multiple rounds of testing and has proven to be safe, so it receives a score of 3."

Answered by AI

Can people with the qualifying condition still enroll in this research project?

"As of March 23,2022, this study is no longer actively recruiting patients. This study was first posted on September 18, 2006. However, if you are seeking other studies, there are 2541 clinical trials for carcinoma and 1305 for conventional surgery that are still recruiting patients."

Answered by AI

How many people can sign up for this trial?

"As of now, this particular clinical trial is no longer recruiting patients. It was initially posted on September 18th, 2006 and was last edited on March 23rd, 2022. If you are looking for other trials, there are presently 2541 trials actively recruiting patients with carcinoma and 1305 trials for conventional surgery actively searching for patients."

Answered by AI

Does this research have any precedent?

"The first trial completed on conventional surgery was back in 1997 and was sponsored by Alfacell. Just one year after the first study, which had 300 participants, conventional surgery was approved for Phase 3 drugs. As of now, there are 1,305 live studies being conducted in 3,436 different cities located in 80 countries."

Answered by AI
~4 spots leftby Apr 2025