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Proton Beam Therapy

Proton Therapy for Craniopharyngioma

Phase 2

Recruiting

Led By Thomas E. Merchant, DO, PhD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ages 0-21 years at the time of diagnosis

Craniopharyngioma diagnosed by histology, cytology, or neuroimaging or intra-operative assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years following start of proton therapy

Awards & highlights

Study Summary

This trial will study if proton therapy is an effective treatment for craniopharyngioma brain tumors with fewer side effects than other forms of radiation therapy.

Who is the study for?

This trial is for individuals aged 0-21 diagnosed with craniopharyngioma, a rare brain tumor. It's open to those who have not had complete surgical removal of the tumor or require observation after radical surgery. Pregnant females and patients previously treated with certain intracystic therapies or radiation are excluded.Check my eligibility

What is being tested?

The study tests intensity-modulated proton therapy (IMPT) for treating craniopharyngioma when surgery doesn't remove all of the tumor, aiming to see if IMPT can be more effective and cause fewer side effects than traditional radiation treatments.See study design

What are the potential side effects?

While specific side effects aren't listed here, generally proton therapy may include risks like fatigue, skin reactions at treatment site, headaches, hair loss near treated area, nausea and potential long-term effects on growth and cognitive development.

Eligibility Criteria

Inclusion Criteria

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

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I was diagnosed with my condition before turning 22.

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My diagnosis of craniopharyngioma was confirmed through tests or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years following start of proton therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years following start of proton therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years following start of proton therapy for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall survival (OS)

Progression-free survival (PFS)

Secondary outcome measures

Compare event-free survival (EFS) with participants treated with conventional radiation therapy at St. Jude Children's Research Hospital

Interventional procedure

Compare survival distributions between groups

+1 more

Other outcome measures

Body Weight Changes

Change in growth factor response

Change in hearing status compared between groups

+10 more

Trial Design

2Treatment groups

Active Control

Group I: Tumor-SurgeryActive Control2 Interventions

Participants who are eligible to undergo surgery to remove the tumor will proceed to surgery. If all tumor is removed, they will be followed over 5 years for outcome comparison to the other participant groups. If the entire tumor is not removed by surgery, participants will receive 6 weeks of proton therapy. They will then be followed for 5 years to collect outcome data for comparison to the other participant groups.

Group II: Tumor-No SurgeryActive Control1 Intervention

Participants whose tumor cannot be resected through surgery will receive 6 weeks of proton therapy. They will then be followed over 5 years for outcome comparison to the other participant groups.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,473 Total Patients Enrolled

4 Trials studying Craniopharyngioma

837 Patients Enrolled for Craniopharyngioma

Thomas E. Merchant, DO, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital

2 Previous Clinical Trials

448 Total Patients Enrolled

Media Library

Intensity-Modulated Proton Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02792582 — Phase 2

Craniopharyngioma Research Study Groups: Tumor-Surgery, Tumor-No Surgery

Craniopharyngioma Clinical Trial 2023: Intensity-Modulated Proton Therapy Highlights & Side Effects. Trial Name: NCT02792582 — Phase 2

Intensity-Modulated Proton Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02792582 — Phase 2

Frequently Asked Questions

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

Are applications to this experiment still being accepted?

"Yes, the clinical trial is currently recruiting patients. Its inception date was June 22nd 2016 and its most recent update was August 22nd 2022 according to clinicialtrials.gov."

Answered by AI

Has the FDA sanctioned Tumor-No Surgery for public use?

"Our team at Power ascribed a score of 2 to the safety profile of Tumor-No Surgery given that we have evidence supporting its protection, but not yet any proof on efficacy."

Answered by AI

What is the participant quota for this research endeavor?

"Affirmative. Online databases, such as clinicaltrials.gov, confirm that this medical trial is currently accepting participants and was initially posted on June 22nd 2016. 140 individuals are needed from 1 site for the duration of the study's research."

Answered by AI

What objectives is this research endeavor seeking to fulfill?

"The primary goal of this 3-year trial is to evaluate Overall Survival (OS) as the main outcome. Secondary objectives include comparing Event-free Survival (EFS), using Kaplan-Meier estimates, between participants treated with Proton Therapy and those receiving conventional radiation therapy at St Jude Children's Research Hospital; contrasting survival distributions for patients who underwent only primary surgical resection versus limited surgery combined with proton therapy through a stratified log-rank test; and assessing differences in survival rates between individuals receiving proton therapy on this protocol against updated cohorts from SJCRH that were given photon irradiation via a further stratified log rank test,"

Answered by AI

Recent research and studies

Physics in Medicine & BiologyJournal

Proton Therapy Delivery Method Affects Dose-averaged Linear Energy Transfer in Patients

Wilson, Lydia J, Fakhriddin Pirlepesov, Vadim Moskvin, Zuofeng Li, Yian Guo, Yimei Li, Thomas E Merchant, and Austin M Faught. 2021. “Proton Therapy Delivery Method Affects Dose-averaged Linear Energy Transfer in Patients”. Physics in Medicine & Biology. IOP Publishing. doi:10.1088/1361-6560/abe835.

clinicaltrials.govStudy

A Phase II Trial of Intensity-Modulated Proton Therapy for Incompletely Resected Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection

2016. "A Phase II Trial of Intensity-Modulated Proton Therapy for Incompletely Resected Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02792582.

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