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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

June 22, 2016

Primary Completion Date

August 31, 2026

Study Completion Date

December 31, 2028

Conditions
Craniopharyngioma
Interventions
RADIATION

Proton Therapy

The protocol-specific radiation dose will be prescribed to a target defined by the use of computerized tomography (CT) and magnetic resonance imaging (MRI). The target will encompass the residual tumor and/or tumor bed and will include a margin mean to treat subclinical microscopic disease. There is no time limit for the interval from surgery or study enrollment to when proton therapy commences. The time course of administration of proton therapy will be 1 treatment/day, 5 days/week, for a period 6 weeks.

PROCEDURE

Surgery

When possible, tumors will be removed surgically prior to proton therapy. If no tumor remains following surgery, no proton therapy will be given, and participants will be followed for 5 years to collect outcome data for comparison between groups.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER