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Proton Beam Therapy

Proton Therapy for Craniopharyngioma

Phase 2

Waitlist Available

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

Must not have

Prior treatment with intracystic P-32 or intracystic bleomycin

Prior history of fractionated radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years following start of proton therapy

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment with P-32 or bleomycin directly into a cyst.

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I have had radiation therapy in parts before.

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

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

Primary study objectives

Overall survival (OS)

Progression-free survival (PFS)

Secondary study objectives

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 study objectives

Body Weight Changes

Change in growth factor response

Change in hearing status compared between groups

+10 more

Awards & Highlights

No Placebo-Only Group

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

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 / 4Eligibility criteria met