Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)
About this trial
Background:
Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.
Objective:
To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.
Eligibility:
People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.
Design:
Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.
Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.
Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.
Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.
Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor.
Age >= 18.
KPS >= 70%.
Previous tumor irradiation to curative-intent doses.
Disqualifiers
Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.
Temozolomide within 2 weeks.
Cytotoxic chemotherapy within 3 weeks.
Any investigational agents within 2 weeks.
Trial design
Design model
Sequential
Treatments tested in this trial
Radiation Therapy
RadiationRadiation therapy will be administered via a linear accelerator using 6 megavoltage (MV) photons or greater.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: 1/Arm 1Experimental treatment 1 intervention
Group B: 2/Arm 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MTD of daily re-irradiation in participants with recurrent grade 4 gliomas
The number of participants experiencing DLTs within the DLT period will be reported for each hypofractionation schema. The MTD will be identified, and the proportion of participants treated with the MTD experiencing DLT will be reported.
Time frame
DLT period (28 days)Secondary outcomes
1
Progression free survival
Time to progression is defined as the interval from the initiation of treatment on protocol to progression or death. Estimates of the median time to progression and of the proportion of participants experiencing progression by 3 years or dying by 5 years will be obtained.
Time frame
Baseline, 30 day safety follow up visit, every 2 months for 2 years, every 3 months for 3rd year, or until progression2
Overall survival
Overall survival is defined as the interval from initiation of treatment on protocol to the death. Estimates of the median time to overall survival will be obtained.
Time frame
Treatment and follow up3
Compliance and feasibility of administering PRO in this participant population
Patient reported outcome forms will be checked versus the timing schedule and considered valid if they fall within the scheduled assessment window. Compliance rates, namely the number of received valid forms over the number of expected forms will be reported.
Time frame
Baseline through 3 years post radiation therapy.4
Tolerability of treatment by assessing adverse events, cognitive function, physical function, and side effect bother
Tolerability of treatment will be assessed by determining the frequency of adverse events among treated participants and reporting the results by maximum grade of event and type of toxicity noted.
Time frame
First radiation treatment administration through 6 months after the last day of radiation. Beyond 6 months after radiation, only adverse events which are serious and related to radiation need to be recorded.Sponsors and contacts
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Source ClinicalTrials.gov