Reduced-Dose Radiotherapy + Temozolomide for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a reduced dose of radiation, combined with the standard drug temozolomide, can slow the progression of glioblastoma, an aggressive brain tumor. Participants will receive a new form of radiotherapy called pulsed reduced dose radiotherapy (pRDR), which uses lower doses in pulses, alongside chemotherapy. This approach may suit those recently diagnosed with glioblastoma who have undergone surgery and are scheduled for radiation and chemotherapy. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who have received other antitumor therapies before enrolling. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that pulsed reduced dose radiotherapy (pRDR) is generally well-tolerated. A large review found low rates of serious side effects, specifically grade 3 toxicity, in patients with recurring aggressive brain tumors, suggesting it is relatively safe for those receiving this treatment.
The trial also uses temozolomide (TMZ), a chemotherapy drug. Studies have shown that temozolomide is safe for older adults and can extend their lives when used after radiation therapy. It has been effective in treating glioblastoma, a type of brain cancer.
Overall, both treatments have demonstrated promising safety in past research, making them reasonable options for those considering joining the trial.12345Why are researchers excited about this trial's treatments?
Pulsed reduced dose-rate radiotherapy (pRDR) is unique because it offers a new approach to treating glioblastoma by combining reduced-dose radiotherapy with temozolomide, a chemotherapy drug. Unlike traditional radiotherapy, which can be intense and taxing on the body, pRDR uses lower doses delivered in pulses, potentially reducing side effects while still fighting cancer cells effectively. Researchers are excited about this treatment because it aims to maintain the effectiveness of standard treatments while improving the quality of life for patients by minimizing harmful side effects.
What evidence suggests that pulsed reduced dose radiotherapy might be an effective treatment for glioblastoma?
Research has shown that pulsed reduced dose radiotherapy (pRDR) can help patients with glioblastoma live longer. Studies have found that pRDR, especially when combined with bevacizumab (a cancer-fighting drug), can significantly extend the time patients live without disease progression and increase overall survival time. In one study, patients lived a median of about 12.6 months after receiving pRDR treatment.
In this trial, participants will receive pRDR in combination with Temozolomide, another well-known treatment for glioblastoma. Research indicates that Temozolomide improves patient outcomes when combined with radiation therapy. Specifically, patients who received both Temozolomide and radiation lived longer than those who had only radiation. This combination is considered a standard treatment to help glioblastoma patients live longer.15678Who Is on the Research Team?
Michael W. Straza
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
Adults diagnosed with new glioblastoma who've had surgery, if needed, and are set for standard chemo-radiotherapy. They should have a life expectancy of over three months, stable health without severe illnesses or prior invasive cancers (except certain skin cancers), and agree to contraception if applicable. Patients can't join if they have recurrent brain tumors, other cancer sites, recent heart issues, connective tissue diseases at high risk for radiation toxicity, kidney failure requiring dialysis, or pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Maximally safe resection of glioblastoma
Chemoradiation
Participants receive pulsed reduced dose-rate radiotherapy combined with chemotherapy
Adjuvant Chemotherapy
Participants receive adjuvant chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- pulsed reduced dose radiotherapy (pRDR)
- Temozolomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor