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NCT02792582 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Craniopharyngioma, sponsored by St. Jude Children's Research Hospital.

Active
Registry status
Phase 2
Development phase
160
Enrollment target
1
Study location

NCT02792582: Active Phase 2 study of Craniopharyngioma, sponsored by St. Jude Children's Research Hospital.

NCT02792582 is a Phase 2 study of Craniopharyngioma that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 160 participants, below the 190-participant average among 6 other Craniopharyngioma trials with a reported enrollment target (16% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02792582, a Phase 2 study of Craniopharyngioma, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
160 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

PFS is defined as the interval of time from the initiation of radiation therapy (RT) until the earliest of the events: death from any cause; and disease progression.

Conditions Studied

Interventions

  • PROCEDURE Surgery
  • RADIATION Proton Therapy

Study Locations (1)

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2016-06-22
Est. Completion 2028-12
Phase Phase 2

What the registry record for NCT02792582 still lists

NCT02792582 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 190-participant average among 6 other Craniopharyngioma trials with a reported enrollment target (16% lower).

The record links to 1 condition, with Craniopharyngioma appearing as the primary indexed condition, and to 2 interventions - of which Surgery is the first listed.

NCT02792582 reports a single indexed study location in Tennessee.

Frequently Asked Questions

What is clinical trial NCT02792582 about?

NCT02792582 is a clinical study titled "A Phase II Trial of Intensity-Modulated Proton Therapy for Incompletely Resected Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection". 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 imba...

What is the current status of trial NCT02792582?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2016-06-22. Estimated completion is 2028-12.

What conditions does trial NCT02792582 study?

This clinical trial studies the following conditions: Craniopharyngioma.

What interventions are being tested in trial NCT02792582?

The interventions under investigation include: Surgery (PROCEDURE), Proton Therapy (RADIATION).

Who is sponsoring clinical trial NCT02792582?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02792582 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT02792582, the US trial registry maintained by the National Library of Medicine. NCT02792582 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.