Trial Summary
What is the purpose of this trial?This phase II trial studies how well temozolomide and radiation therapy work in treating patients with IDH wildtype historically lower grade gliomas or non-histological molecular glioblastomas. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. Drugs used in chemotherapy, such as temozolomide, 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. The goal of this clinical research study is to compare receiving new radiation therapy doses and volumes to the prior standard treatment for patients with historically grade II or grade III IDH wild-type gliomas, which may now be referred to as IDH wildtype molecular glioblastomas at some institutions. Receiving temozolomide in combination with radiation therapy may also help to control the disease.
Is Radiation Therapy with the drug Temozolomide a promising treatment for brain cancer?Yes, combining Radiation Therapy with the drug Temozolomide shows promise for treating brain cancer, especially in cases where the cancer has spread to the brain from lung cancer. Studies suggest this combination can be effective and safe, offering hope for patients with challenging brain cancer conditions.25789
What safety data exists for chemotherapy and radiation treatment for brain cancer?The safety data for chemotherapy and radiation treatment, specifically using temozolomide (TMZ) and various forms of radiotherapy, indicate that these treatments are generally well-tolerated with some common mild to moderate side effects such as fatigue, nausea, vomiting, thrombocytopenia, and neutropenia. Severe hematologic adverse events, including myelodysplastic syndrome and aplastic anemia, have been reported but are less common. Studies have shown that combining TMZ with different radiotherapy techniques, such as intensity-modulated radiation therapy (IMRT) and whole-brain radiotherapy (WBRT), can improve treatment efficacy and quality of life for patients with brain metastases from non-small cell lung cancer (NSCLC).23689
What data supports the idea that Chemotherapy + Radiation for Brain Cancer is an effective treatment?The available research shows that combining chemotherapy with radiation is more effective than using radiation alone for treating certain types of brain cancer. For example, one study found that using the drug temozolomide (TMZ) with radiation therapy improved survival rates for patients with high-grade gliomas compared to radiation alone. Another study indicated that this combination treatment is effective for brain metastases from non-small cell lung cancer. These findings suggest that the combination of chemotherapy and radiation can be a more powerful approach to treating brain cancer than radiation by itself.12489
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, since prior chemotherapy or radiotherapy for any brain tumor is an exclusion criterion, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators or your doctor for specific guidance.
Eligibility Criteria
This trial is for patients with specific brain tumors called IDH wildtype gliomas or molecular glioblastomas, who haven't had chemotherapy or radiotherapy before. They should be able to undergo MRI scans, have a good performance status (able to carry out daily activities), and their blood counts and liver function tests need to be within certain limits.Inclusion Criteria
My brain tumor is a high-grade glioma or glioblastoma without IDH mutation.
Exclusion Criteria
My cancer has spread to the lining of my brain and spinal cord.
I was hospitalized for heart failure that affects my daily activities within the last year.
My diagnosis is either gliosarcoma (grade IV) or pilocytic astrocytoma (grade I).
I have a serious heart rhythm problem that is not well-controlled.
I am currently on IV antibiotics for a bacterial or fungal infection.
I do not have a severe lung condition that requires hospital care right now.
I have severe kidney disease requiring dialysis.
I have had chemotherapy or radiotherapy for a brain tumor before.
I have had radiation therapy to my head or neck before.
My brain cancer is present in multiple areas.
Treatment Details
The study is testing the effectiveness of combining temozolomide (a chemotherapy drug) with radiation therapy in treating these brain tumors. The goal is to see if this combination works better than previous standard treatments in controlling the disease.
1Treatment groups
Experimental Treatment
Group I: Treatment (temozolomide, radiation therapy)Experimental Treatment4 Interventions
Patients receive temozolomide PO daily and radiation therapy over 5 days a week (weekdays only) for 6 weeks. Beginning 28 days after the last dose of radiation therapy, patients receive temozolomide PO for 12 months in the absence of disease progression or unacceptable toxicity.
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇺🇸 Approved in United States as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇦 Approved in Canada as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇯🇵 Approved in Japan as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇳 Approved in China as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇭 Approved in Switzerland as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a clinic near you
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Phase II study of temozolomide and thalidomide with radiation therapy for newly diagnosed glioblastoma multiforme. [2018]The chemotherapeutic agent temozolomide (TMZ) and the antiangiogenic agent thalidomide have both demonstrated antitumor activity in patients with recurrent malignant glioma. The objectives of this study were to determine if the combined strategy of these oral agents with radiation therapy (RT) is associated with an improved median survival of patients with newly diagnosed glioblastoma multiforme and to evaluate toxicity.
Oral temozolomide in heavily pre-treated brain metastases from non-small cell lung cancer: phase II study. [2018]The primary tumour type most likely to metastasize to the brain is lung cancer. In heavily pre-treated patients, limited therapeutic option is available and the results of availability therapies reported in literature are disappointing. The present phase II study was designed to assess the efficacy and safety of temozolomide (TMZ) as palliative treatment for brain metastases (BrM) in NSCLC patients pre-treated with WBRT and at least one line of chemotherapy for metastatic brain disease.
Temozolomide-related hematologic toxicity. [2018]Temozolomide (TMZ) is an oral alkylating agent used for the treatment of recurrent or newly diagnosed malignant gliomas with significant survival benefit. TMZ is generally well tolerated and safe. The most common side effects are mild to moderate, and are represented by fatigue, nausea, vomiting, thrombocytopenia, and neutropenia. However severe hematologic adverse events (HAEs), including myelodysplastic syndrome and aplastic anemia, have also been reported. In this review we present an overview of the available literature of HAEs after exposure to TMZ.
Temozolomide and radiotherapy versus radiotherapy alone in high grade gliomas: a very long term comparative study and literature review. [2018]Temozolomide (TMZ) is the first line drug in the care of high grade gliomas. The combined treatment of TMZ plus radiotherapy is more effective in the care of brain gliomas then radiotherapy alone. Aim of this report is a survival comparison, on a long time (>10 years) span, of glioma patients treated with radiotherapy alone and with radiotherapy + TMZ.
Brain Radiotherapy plus Concurrent Temozolomide versus Radiotherapy Alone for Patients with Brain Metastases: A Meta-Analysis. [2018]We performed a meta-analysis of randomized clinical trials to compare the efficacy of brain radiotherapy (RT) combined with temozolomide (TMZ) versus RT alone as first-line treatment for brain metastases (BM).
Intensity-modulated radiation therapy combined with concomitant temozolomide for brain metastases from lung adenocarcinoma. [2020]Short-term efficacy, adverse effects and the impact on quality of life (QoL) of a concomitant treatment with intensity-modulated radiation therapy (IMRT) and temozolomide (TMZ) in patients with brain metastases (BMs) from lung adenocarcinoma were evaluated. This study sought to confirm the benefit of adding TMZ to IMRT in patients with BMs from lung adenocarcinoma. Nine patients were enrolled and received a dose of 30 Gy in 10 daily fractions to clinical tumor volume (CTV) according to IMRT, then additional dose of 9 Gy in 3 fractions of IMRT was delivered to gross tumor volume (GTV) only with concomitant TMZ (75 mg/m2/day) orally during RT for 3 weeks. One patient achieved complete response (CR) (11.1%), 6 patients obtained partial response (PR) (66.7%), and there were no patients in progression. Therefore, objective response (OR) reached 77.8%. The main adverse effects included neutropenia, anemia, vomiting, fatigue and dizziness. Grade ≥3 of hematologic toxicities did not occur. However, the other 9 patients who received only intensity-modulated radiation had much worse results. The CR was 0, PR rate was 44.4%, OR rate was 44.4%. The results indicated that the benefit of adding TMZ to IMRT was confirmed in patients with BMs from lung adenocarcinoma. The treatment was active, a significant OR was observed, and achieved an improvement in QoL demonstrated by QoL grade (p<0.05).
A Phase II Trial of Concurrent Temozolomide and Hypofractionated Stereotactic Radiotherapy for Complex Brain Metastases. [2020]Complex brain metastases (BMs), such as large lesions, lesions within or close to eloquent locations, or multiple recurrent/progressive BMs, remain the most challenging forms of brain cancer because of decreased intracranial control rates and poor survival. In the present study, we report the results from a single institutional phase II trial of concurrent temozolomide (TMZ) with hypofractionated stereotactic radiotherapy (HFSRT) in patients with complex brain metastases, including assessment of its feasibility and toxicity.
Efficacy of synchronous stereotactic radiotherapy with temozolomide combined with whole brain radiotherapy in treating brain metastases originating from non-small cell lung cancer. [2021]To investigate the efficacy and safety of synchronous stereotactic radiotherapy (SRT) with temozolomide (TMZ) combined with whole brain radiotherapy (WBRT) in treating brain metastases originating from non-small cell lung cancer (NSCLC).
Response and safety of whole-brain radiotherapy plus temozolomide for patients with brain metastases of non-small-cell lung cancer: A meta-analysis. [2022]The aim of the present work was to investigate the response and safety of whole-brain radiotherapy (WBRT) plus temozolomide (TMZ) for patients with brain metastases of non-small-cell lung cancer (NSCLC).