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

StatusActive, Not Recruiting
PhasePhase 2
Started2016-06-22
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 25 months later Aug 2026 → Oct 2028
See other at-risk trials from St. Jude Children's Research Hospital

Amendment history

2026-09-23
critical
Primary completion pushed: 2026-08 → 2028-10
2026-06-15
minor
4 amendments v17-v20
4 re-verifications since 2025-11-11, no change to tracked fields
2025-06-10
minor
Study Status v16
Primary completion date2025-06→2026-08
Completion date2027-06→2028-12
2025-02-17
minor
Study Status, Study Design v15
Enrollment targetestimated 140→confirmed 160
2024-08-23
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v14
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
Show 13 earlier versions
2023-08-22
minor
6 amendments v8-v13
6 re-verifications since 2018-10-10, no change to tracked fields
2017-09-26
minor
Study Status v7
Primary completion date2025-06-30→2025-06
Completion date2027-06-30→2027-06
2017-08-21
minor
Study Status v6
Re-verified, no change to tracked fields
2017-04-24
minor
Study Status, Arms and Interventions v5
InterventionsContrast media (Drug), Proton Therapy (Radiation), Proton therapy (Device), Surgery (Procedure)→Proton Therapy (Radiation), Surgery (Procedure)
2017-04-17
minor
Study Status, Oversight, Arms and Interventions v4
InterventionsProton Therapy (Radiation), Surgery (Procedure)→Contrast media (Drug), Proton Therapy (Radiation), Proton therapy (Device), Surgery (Procedure)
2017-03-29
minor
Study Status, Oversight v3
Primary completion date2025-06→2025-06-30
Completion date2027-06→2027-06-30
Start date2016-06→2016-06-22
2016-12-27
minor
Study Status v2
Re-verified, no change to tracked fields
2016-06-21
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2016-06-01
minor
Original filing
Craniopharyngioma is a rare brain tumor that affects both children and adults. It arises in a region of the brain near the pituitary gland, visual pathways, and central blood vessels. Patients often present with headache, loss of vision or delayed growth. In some instances they may present with imbalance of water and salts in the body. The treatment for craniopharyngioma may be radical surgery or a combination of surgery and radiation therapy. In some instances surgery is not required. If the tumor cannot be completely removed, radiation therapy may be required. In this study we will use the most advanced form of proton therapy which is called intensity-modulated proton therapy. This is a newer form of radiation therapy which has a number of advantages over older forms of proton therapy and conventional radiation therapy using x-rays. The main goal of this study is to learn if proton therapy will effectively treat patients with craniopharyngioma brain tumors and reduce side effects compared to more traditional forms of radiation therapy.
Trial Details
NCT Number NCT02792582
Lead Sponsor St. Jude Children's Research Hospital
Conditions Craniopharyngioma
Enrollment 160 participants
Start Date 2016-06-22
Primary Completion 2028-10 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-22