Clinical Trial: Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase 2 Trial of Response-Based Radiation Therapy for Patients With Localized Central Nervous System Germ Cell Tumors (CNS GCT)
Brief Summary: Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy with radiation therapy may kill more tumor cells. This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors.
Detailed Summary:
PRIMARY OBJECTIVES:
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 with localized nongerminomatous germ cell tumor (NGGCT) who have a magnetic resonance imaging (MRI) and tumor marker criteria (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 with localized primary central nervous system (CNS) germinoma who present with serum and/or CSF human chorionic gonadotropin-beta (hCGβ) =< 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 (This objective will be assessed independently for the two strata).
SECONDARY OBJECTIVES:
Original Primary Outcome:
- 3-year PFS rate with NGGCT
- PFS distribution of localized CNS germinoma at 3 years
- Neurocognitive function from baseline to up to 5 years using the ALTE07C1 protocol
Current Secondary Outcome:
- Estimation of the PFS distribution of patients with NGGCT treated with IFR [ Time Frame: Up to 5 years ]Kaplan-Meier estimates will be provided.
- Estimation of the OS distribution of patients with NGGCT treated with IFR assessed [ Time Frame: Up to 5 years ]Kaplan-Meier estimates will be provided.
- Estimation of the PFS distribution of patients with localized germinoma patients and CSF serum hCGβ of 50 mIU/mL or less or CSF serum hCGβ greater than 50 mIU/mL and less than or equal to 100 mIU/mL [ Time Frame: Up to 5 years ]Kaplan-Meier estimates will be provided.
- Estimation of the OS distribution of patients with localized germinoma patients and CSF serum hCGβ of 50 mIU/mL or less or CSF serum hCGβ greater than 50 mIU/mL and less than or equal to 100 mIU/mL [ Time Frame: Up to 5 years ]Kaplan-Meier estimates will be provided.
Original Secondary Outcome:
- Estimation of the PFS distribution of patients with NGGCT treated with IFR assessed up to 5 years
- Estimation of the OS distribution of patients with NGGCT treated with IFR assessed up to 5 years
- Estimation of the PFS distribution of patients with localized germinoma patients and CSF serum hCGβ ≤ 50 mIU/mL or CSF serum hCGβ > 50 mIU/mL and ≤ 100 mIU/mL assessed up to 5 years
- Estimation of the OS distribution of patients with localized germinoma patients and CSF serum hCGβ ≤ 50 mIU/mL or CSF serum hCGβ > 50 mIU/mL and ≤ 100 mIU/mL assessed up to 5 years
Information By: Children's Oncology Group
Dates:
Date Received: May 18, 2012
Date Started: May 2012
Date Completion: January 2024
Last Updated: February 8, 2017
Last Verified: February 2017
