Phase 2 Trial of Response-Based Radiation Therapy for Patients With Localized Central Nervous System Germ Cell Tumors (CNS GCT)
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
AJ (Andria) Froemming
afroemming@unmc.edu
Summary
I. To determine, as measured by the 3-year progression-free survival (PFS) rate and patterns of failure, whether dose
and volume of irradiation can be safely reduced to 30.6 Gy whole ventricular-field irradiation (WVI) plus 23.4 Gy
primary site boost instead of 36 Gy craniospinal irradiation (CSI) plus primary site boost in the subgroup of children
and young adults (ages 3 to =< 21 years) with localized nongerminomatous germ cell tumor (NGGCT) who have a
magnetic resonance imaging (MRI) and tumor marker criteria (cerebrospinal fluid [CSF] and serum) for confirmed
complete response (CR) or partial response (PR) to induction chemotherapy and negative serum and cerebrospinal
fluid (CSF) tumor markers OR in patients who have less than a PR after induction chemotherapy with negative tumor
markers who undergo a second-look surgery and are found to have only mature teratoma, residual scar or fibrosis
and fit the definition of CR/PR after second-look surgery.
II. To determine, as measured by the 3-year PFS rate and patterns of failure, whether simplified chemotherapy
followed by dose-reduced radiation therapy is effective for treating children and young adults (ages 3 to =< 21
years) with localized primary central nervous system (CNS) germinoma who present with serum and/or CSF human
chorionic gonadotropin-beta (hCGbeta) =< 50 mIU/mL.
III. To prospectively evaluate and longitudinally model the cognitive, social, and behavioral functioning of children
and young adults who are treated with reduced radiation dose and volume of irradiation in Stratum 1 (NGGCT) and
with dose-reduced radiation therapy in Stratum 2 (germinoma) using the ALTE07C1 protocol.