Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly D… (NCT02724579) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma
United States, Australia, Canada45 participantsStarted 2017-11-17
Plain-language summary
This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.
Who can participate
Age range
3 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must be greater than or equal to 3 years and less than 22 years of age at the time of enrollment
* Patients must be newly diagnosed and have:
* Eligibility confirmed by rapid central pathology and molecular screening review on APEC14B1:
* Classical histologic type (non LC/A) WNT medulloblastoma
* Positive nuclear beta-catenin by immunohistochemistry (IHC)
* Positive for CTNNB1 mutation by Sanger sequencing
* Negative for MYC and MYCN by fluorescence in situ hybridization (FISH)
* Patient must have negative lumbar cerebrospinal fluid (CSF) cytology
* Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study; patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status; patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated; patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively
* Patients must have eligibility confirmed by Rapid Central Imaging Review on APEC14B1; patients must have =\< 1.5 cm\^2 maximal cross-sectional area of residual tumor; whole brain magnetic resonance imaging (MRI) with and without gadoliniu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial specifically targets WNT-driven medulloblastoma — how do we confirm that my child's tumor actually has this WNT molecular subtype, and has that testing already been done?
2Since this is a Phase 2 trial testing whether the radiation dose to the spine and brain can be safely reduced, what do the doctors running this study currently know about whether lowering the dose still controls the cancer as well as the standard higher dose?
3The trial is no longer enrolling new patients — does that mean there are results available that you can share with me, and how might those early findings influence the treatment approach you'd recommend for my child?
4Progression-free survival is what this trial is measuring — what does that mean in practical terms for my child's situation, and how does it compare to the progression-free survival seen with the standard full-dose craniospinal radiation approach?
5Given that this trial reduces radiation doses partly to limit long-term side effects on a young child's developing brain, how would you weigh the potential benefit of lower toxicity against any uncertainty about whether it controls the disease as effectively as standard treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival (PFS)
Timeframe: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 10 years