Chemo-Radiation for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores different methods of using chemo-radiotherapy to treat glioblastoma, a type of brain cancer. Researchers compare two radiation schedules: one with 15 treatments and another with 5 treatments, both using the chemotherapy drug temozolomide, to determine which is more effective. It is open to patients who have already received significant radiation treatment and have a doctor-confirmed diagnosis of glioblastoma. Researchers will monitor participants to assess the effectiveness of each treatment plan and its impact on daily life. As a Phase 1, Phase 2 trial, this study aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage research.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications. It allows for any number or type of prior chemotherapy, and you may receive additional treatments like cetuximab if your doctor agrees.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study on radiation therapy for glioblastoma showed promising safety results, including a reduction in severe drops in white blood cells, which benefits patients' immune systems. Another study found that using advanced techniques like MRI to guide treatment improved safety and survival rates compared to older methods.
Research has also shown that temozolomide, a chemotherapy drug used in this trial, is generally well-tolerated. It helped patients with glioblastoma live longer when used after radiation therapy. Some patients may experience side effects like low red blood cell counts (anemia) or low white blood cell counts (neutropenia), but these are often manageable.
Overall, previous studies have shown both radiation therapy and temozolomide to be safe, but like any treatment, there might be risks. Discussing these with a healthcare provider is important when considering joining a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for glioblastoma because they explore new radiation schedules combined with temozolomide, potentially offering more flexibility and effectiveness. Unlike the typical standard of care which involves longer radiation courses, these approaches test shorter, intensified radiation regimens: one with 40 Gy over 15 fractions and another with 25 Gy over just 5 fractions. This could mean a quicker treatment process with less disruption to patients' lives. Additionally, both regimens integrate temozolomide, an established chemotherapy drug, aiming to enhance the overall therapeutic impact while possibly reducing side effects.
What evidence suggests that this trial's treatments could be effective for glioblastoma?
This trial will compare two radiation therapy schedules for glioblastoma: one group will receive 40 Gy in 15 fractions, and another will receive 25 Gy in 5 fractions. Studies have shown that radiation therapy, whether given in 5 or 15 sessions, effectively treats glioblastoma by using strong rays to destroy cancer cells. Research comparing different radiation schedules suggests that shorter 5-session treatments can offer similar results to longer ones in terms of survival and tumor control. In this trial, all participants will also receive Temozolomide, a chemotherapy drug known to significantly improve survival rates when combined with radiation therapy. Patients treated with both temozolomide and radiation have demonstrated better overall survival compared to those receiving only radiation. Together, these treatments have a proven track record of helping patients with glioblastoma live longer and manage their condition more effectively.12367
Who Is on the Research Team?
John Flickinger, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
Adults diagnosed with WHO Grade IV Glioblastoma who can consent, have acceptable liver and kidney function tests, normal blood counts, are not pregnant or breastfeeding, and do not have distant cancer spread. Prior chemotherapy is allowed but no prior radiotherapy to the brain. Participants must be able to follow the study plan as assessed by the investigator.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemo-radiation
Patients receive either 40 Gy in 15 fractions or 25 Gy in 5 fractions with concurrent temozolomide
Adjuvant
Standard monthly 5-day cycles of TMZ-chemo at 150 mg/m^2 per day for up to 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Radiation Therapy
- Temozolomide
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
John Flickinger
Lead Sponsor