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Alkylating agents

Chemotherapy + Radiation Therapy for Brain Cancer

Q: What is the cohort size of individuals participating in this research?

Affirmative. According to the information made available on clinicaltrials.gov, recruitment for this research is currently underway following its initial posting on June 4th 2021. Additionally, 160 individuals are expected to participate at 85 different medical centres.

Q: What maladies can be addressed through the use of Radiation Therapy?

Radiation Therapy is the preferred method of treatment for Merkel Cell <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> and can be employed to manage a variety of diseases including <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, early onset tumours, and <a href="https://www.withpower.com/clinical-trials/prostate">prostate</a> carcinoma.

Q: Has there been prior research on the efficacy of Radiation Therapy?

In 1997, City of Hope Comprehensive <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center began researching radiation therapy and has since conducted 2740 clinical trials. Currently, 1622 studies are actively recruiting participants with many being held in <a href="https://www.withpower.com/clinical-trials/iowa">Iowa</a> City, Iowa.

Q: Does this trial accept new participants?

To become a participant in this clinical trial, one must be between 3 and 30 years old and have been diagnosed with embryonal carcinoma. At present, the team is aiming to enroll 160 patients.

Q: What potential risks may be associated with Radiation Therapy?

Based on the available data, our team at Power deduced that Radiation Therapy is relatively safe and merits a score of 2. This Phase 2 trial has provided some evidence for safety but lacks any empirical proof regarding efficacy.

Q: Are there any regional outposts executing this experiment?

This trial is enrolling at University of <a href="https://www.withpower.com/clinical-trials/iowa">Iowa</a>/Holden Comprehensive <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Iowa City, as well as Saint Jude Midwest Affiliate in Peoria and <a href="https://www.withpower.com/clinical-trials/oregon">Oregon</a> Health and Science University in Portland. In addition to these three sites, there are 85 other locations recruiting patients.

Q: Are geriatric patients included in the parameters of this research?

This research project requires that participants are between the ages of 3 and 30, as outlined in their eligibility criteria.

Q: What is the chief aim of this research endeavor?

The primary assessment of this clinical trial, conducted over a two-year period, is the spinal failure rate. Secondary outcomes take into consideration radiographic complete response (CR) and partial response (PR), marker normalization post high-dose chemotherapy with peripheral stem cell rescue (HDCSCR) as well as after induction/second-look surgery in patients treated with such medications. Additionally, an exploratory analysis will be done to examine radiation dose distribution's role in disease recurrence/failure.

Q: Are new participants being enrolled into this research trial at present?

Affirmative. The details on clinicaltrials.gov imply that recruitment for this investigation is still ongoing, which began on June 4th 2021 and was updated most recently on November 28 2022. A total of 160 individuals will be recruited from 85 different sites .

Phase 2

Recruiting

Led By Shannon M MacDonald

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

Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or > 10 ng/mL or human chorionic gonadotropin (hCG) beta > 100 mIU/mL. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 21 days prior to enrollment and within 35 days prior to start of protocol therapy [repeat if necessary]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy [repeat if necessary]). Basal ganglia or other primary sites are excluded

Patients must be >= 3 years and < 30 years at the time of study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study Summary

This trial is studying how well different combinations of chemotherapy and radiation therapy work in treating patients with non-germinomatous germ cell tumors that have not spread to other parts of the brain or body.

Who is the study for?

This trial is for children and young adults aged 3 to less than 30 with a localized brain tumor called NGGCT, without prior tumor-directed therapy other than surgery or steroids. Participants must have specific blood counts, organ function, no metastatic disease, not be pregnant or breastfeeding, and agree to use contraception if sexually active.Check my eligibility

What is being tested?

The study tests how well chemotherapy combined with radiation therapy works based on the patient's response to initial chemotherapy. It aims to optimize treatment by either adjusting radiation levels or using higher dose chemo followed by stem cell transplant before conventional radiation.See study design

What are the potential side effects?

Possible side effects include those typical of chemotherapy such as nausea, hair loss, fatigue, risk of infection due to low blood counts; and from radiation like skin irritation and fatigue. High-dose chemo may also cause mouth sores and increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a specific brain tumor with certain marker levels.

Select...

I am between 3 and 29 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Failure rate

Spinal failure rate

Secondary outcome measures

Overall survival (OS)

Patterns of disease recurrence/failure

Progression-free survival (PFS)

+2 more

Other outcome measures

Change in adaptive functioning within each arm

Change in health-related quality of life between the two treatment arms

Change in health-related quality of life within each arm

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Plan B (chemotherapy, HDCSCR, second-look surgery if needed)Experimental Treatment13 Interventions

See Outline in Detailed Description.

Group II: Plan A (chemotherapy, WVSCI, second-look surgery if needed)Experimental Treatment11 Interventions

See Outline in Detailed Description.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Carboplatin

2014

Completed Phase 3

~6670

Etoposide

2010

Completed Phase 3

~2440

Filgrastim

2000

Completed Phase 3

~3670

Ifosfamide

2010

Completed Phase 4

~2980

Mesna

2003

Completed Phase 2

~1380

Pegfilgrastim

2013

Completed Phase 3

~4410

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

Radiation Therapy

2017

Completed Phase 3

~7250

Thiotepa

2008

Completed Phase 3

~2150

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

454 Previous Clinical Trials

237,780 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,845 Total Patients Enrolled

Shannon M MacDonaldPrincipal InvestigatorChildren's Oncology Group

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04684368 — Phase 2

Central Nervous System Tumor Research Study Groups: Plan A (chemotherapy, WVSCI, second-look surgery if needed), Plan B (chemotherapy, HDCSCR, second-look surgery if needed)

Central Nervous System Tumor Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04684368 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684368 — Phase 2

Frequently Asked Questions

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

What is the cohort size of individuals participating in this research?

"Affirmative. According to the information made available on clinicaltrials.gov, recruitment for this research is currently underway following its initial posting on June 4th 2021. Additionally, 160 individuals are expected to participate at 85 different medical centres."

Answered by AI

What maladies can be addressed through the use of Radiation Therapy?

"Radiation Therapy is the preferred method of treatment for Merkel Cell cancer and can be employed to manage a variety of diseases including leukemia, early onset tumours, and prostate carcinoma."

Answered by AI

Has there been prior research on the efficacy of Radiation Therapy?

"In 1997, City of Hope Comprehensive Cancer Center began researching radiation therapy and has since conducted 2740 clinical trials. Currently, 1622 studies are actively recruiting participants with many being held in Iowa City, Iowa."

Answered by AI

Does this trial accept new participants?

"To become a participant in this clinical trial, one must be between 3 and 30 years old and have been diagnosed with embryonal carcinoma. At present, the team is aiming to enroll 160 patients."

Answered by AI

What potential risks may be associated with Radiation Therapy?

"Based on the available data, our team at Power deduced that Radiation Therapy is relatively safe and merits a score of 2. This Phase 2 trial has provided some evidence for safety but lacks any empirical proof regarding efficacy."

Answered by AI

Are there any regional outposts executing this experiment?

"This trial is enrolling at University of Iowa/Holden Comprehensive Cancer Center in Iowa City, as well as Saint Jude Midwest Affiliate in Peoria and Oregon Health and Science University in Portland. In addition to these three sites, there are 85 other locations recruiting patients."

Answered by AI

Are geriatric patients included in the parameters of this research?

"This research project requires that participants are between the ages of 3 and 30, as outlined in their eligibility criteria."

Answered by AI

What is the chief aim of this research endeavor?

"The primary assessment of this clinical trial, conducted over a two-year period, is the spinal failure rate. Secondary outcomes take into consideration radiographic complete response (CR) and partial response (PR), marker normalization post high-dose chemotherapy with peripheral stem cell rescue (HDCSCR) as well as after induction/second-look surgery in patients treated with such medications. Additionally, an exploratory analysis will be done to examine radiation dose distribution's role in disease recurrence/failure."

Answered by AI

Are new participants being enrolled into this research trial at present?

"Affirmative. The details on clinicaltrials.gov imply that recruitment for this investigation is still ongoing, which began on June 4th 2021 and was updated most recently on November 28 2022. A total of 160 individuals will be recruited from 85 different sites ."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

2021. "A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04684368.

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