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A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection

StatusActive, Not Recruiting
PhasePhase 2
Started2011-08-22
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 58 months later Jul 2026 → Jun 2031
See other at-risk trials from St. Jude Children's Research Hospital

Amendment history

2026-08-17
Study Status v32
Primary completion pushed: 2026-07 → 2031-06
Completion pushed: 2026-07 → 2031-06
2026-06-15
4 amendments v28-v31
4 re-verifications since 2024-08-27, no change to tracked fields
2023-09-25
Study Status v27
Primary completion date2023-07→2026-07
Completion date2023-07→2026-07
2022-09-23
Study Status v26
Primary completion date2022-07→2023-07
Completion date2022-07→2023-07
2022-01-05
Study Status v25
Primary completion date2021-12→2022-07
Completion date2021-12→2022-07
Show 24 earlier versions
2021-02-12
Study Status v24
Primary completion date2021-05→2021-12
Completion date2021-05→2021-12
2020-10-08
3 amendments v21-v23
3 re-verifications since 2018-10-02, no change to tracked fields
2017-09-28
Study Status v20
Primary completion date2021-05-31→2021-05
Completion date2021-05-31→2021-05
2017-04-12
Study Status, Oversight, Arms and Interventions v19
InterventionsProton Therapy (Radiation), Radical Surgery or Limited Surgery (Procedure)→Proton Therapy (Device), Radical Surgery or Limited Surgery (Procedure), ^1^1C-methionine (Drug), ^1^8F-fluorodeoxyglucose (Drug)
2017-03-30
Study Status, Oversight v18
Primary completion date2021-05→2021-05-31
Completion date2021-05→2021-05-31
Start date2011-08→2011-08-22
2016-07-22
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v17
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2022-08→2021-05
Completion date2022-08→2021-05
Enrollment targetestimated 140→confirmed 112
Study sitesdetails revised at 2 of 2 sites
2016-05-13
3 amendments v14-v16
3 re-verifications since 2016-03-08, no change to tracked fields
2015-09-11
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 2 sites
2015-03-26
Study Identification, Study Status v12
Re-verified, no change to tracked fields
2015-03-19
Study Identification, Study Status, Contacts/Locations v11
Study sites2 entries, revised
University of Florida Health Proton Therapy Institute
2014-10-17
3 amendments v8-v10
3 re-verifications since 2013-10-25, no change to tracked fields
2013-04-23
Study Identification, Study Status, Study Design, Arms and Interventions, Eligibility v7
Enrollment target130→140
InterventionsProton Therapy (Radiation), Radical Surgery or limited surgery and proton therapy (Procedure)→Proton Therapy (Radiation), Radical Surgery or Limited Surgery (Procedure)
Eligibility criteria-6 characters
Inclusion Criteria: Craniopharyngioma newly diagnosed by histology, cytology or neuroimaging. Patients [...]
Study title-23 characters
A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma andor Observation for Craniopharyngioma After Radical Resection
2012-10-22
Study Status v6
Re-verified, no change to tracked fields
2012-04-20
Study Status, Arms and Interventions v5
InterventionsRadiation and Proton Therapy (Radiation), Radical Surgery Vs limited surgery and proton therapy (Procedure)→Proton Therapy (Radiation), Radical Surgery or limited surgery and proton therapy (Procedure)
2012-03-28
Study Status, Study Design, Outcome Measures, Contacts/Locations v4
Primary completion date2019-06→2022-08
Completion date2019-08→2022-08
Study sites1→2
Secondary endpointsdetails revised at 2 of 2 entries
2011-09-14
Study Status, Study Description, Contacts/Locations v3
Study sitescontacts updated at 1 of 1 site
2011-09-08
Study Status, Sponsor/Collaborators, References v2
Re-verified, no change to tracked fields
2011-08-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2011-08-16
Original filing
The goal of this study is to determine the feasibility and safety of treating patients with a brain tumor known as craniopharyngioma with limited surgery and a 5mm clinical target volume margin in combination with proton therapy. Proton therapy will be indicated for patients with diagnosed craniopharyngioma who are not treated with radical surgery (gross-total resection). Irradiated patients will undergo a series of evaluations designed to evaluate the effects of proton therapy. Similar evaluations will be performed on patients treated with radical surgery. Proton therapy will include 30 treatment fractions administered 5 days per week. Weekly imaging will be a requirement to monitor for cyst expansion and target volume deformation.
Trial Details
NCT Number NCT01419067
Lead Sponsor St. Jude Children's Research Hospital
Conditions Craniopharyngioma
Enrollment 112 participants
Start Date 2011-08-22
Primary Completion 2031-06 (estimated)
Study Completion 2031-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-19