Hypofractionated Radiation Therapy for Brain Cancer

Recruiting at 1 trial location

Overseen By Clinical Trials Referral Office

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Previous brain radiation, chemotherapy, NF1 or NF2, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering hypofractionated radiation therapy for individuals with diffuse midline gliomas, a type of brain cancer. Instead of the usual six-week treatment, the trial tests whether a shorter, two-week version can enhance results and quality of life. It suits those with diffuse midline gliomas in the brainstem area who experience nerve problems or balance issues. Participants must be able to undergo an MRI and speak English or Spanish. This trial may provide an alternative path for those facing this challenging condition. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering hope for improved outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have received previous radiation or chemotherapy, you cannot participate in this trial.

What prior data suggests that hypofractionated radiation therapy is safe for brain cancer patients?

Research has shown that a shorter, more intense schedule of radiation therapy, known as hypofractionated radiation therapy, is generally safe for treating brain tumors. Studies have found that this therapy is effective and well-tolerated for tumors in the head and neck area, including some brain cancers.

The main safety concern is radiation's potential impact on healthy brain tissue, a side effect known as radiation-induced brain toxicity. However, research indicates that this side effect is manageable. While risks exist, they are considered acceptable when treating cancer.

This treatment is not entirely new; it has been used for other types of tumors with promising results. This experience increases confidence in its safety, although individual responses can vary. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for brain cancer?

Unlike traditional radiation therapy for brain cancer, hypofractionated radiation therapy delivers higher doses of radiation in fewer sessions. This approach potentially shortens the treatment time, which can be especially beneficial for patients who may find frequent hospital visits challenging. Researchers are excited because this method could maintain or even improve effectiveness while minimizing overall exposure to radiation, reducing side effects and improving the patient's quality of life. Additionally, the use of MRI and PET-CT scans throughout the treatment allows for precise monitoring and adjustment, potentially leading to better outcomes.

What evidence suggests that hypofractionated radiation therapy might be an effective treatment for brain cancer?

Research shows that hypofractionated radiation therapy (HFRT) is gaining popularity for treating brain and spinal cord tumors due to its potential benefits. This trial will evaluate HFRT, which has proven effective, especially for patients requiring repeat radiation treatment. For instance, one study found that combining HFRT with the drug temozolomide was effective for patients with glioblastoma, a type of brain cancer. Although some higher-dose radiation plans did not improve survival rates compared to traditional methods, HFRT remains promising because it involves shorter treatment times and may enhance quality of life. ^{2 3 4 6 7}

Who Is on the Research Team?

Anita Mahajan, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for patients with a brain tumor called diffuse midline glioma. Eligible participants include those who have had or can undergo a biopsy, are able to give consent, complete questionnaires in English or Spanish, and return for follow-up. It's not for pregnant women, nursing mothers, people with severe diseases that could affect the study results, or those who've had prior brain radiation or chemotherapy.

Inclusion Criteria

Negative urine pregnancy test completed =< 7 days prior to registration, for women of childbearing potential only

If my brainstem lesion doesn't meet specific criteria, I must have a biopsy or I'll be withdrawn from the study.

My MRI shows a tumor in the middle of my brain stem affecting over half of the pons area, and I have symptoms like nerve issues, movement problems, or coordination difficulties.

Exclusion Criteria

I have been diagnosed with neurofibromatosis type 1 or 2.

I haven't had any cancer except for certain types in the last 5 years.

I have had chemotherapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hypofractionated radiation therapy over 10 fractions. Patients who experience progression undergo up to 2 retreatment courses.

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1 month, every 2 months for year 1, every 3 months for year 2, then every 6 months for year 3.

3 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy

Trial Overview The SPORT-DMG Study tests if giving hypofractionated radiation therapy over 2 weeks instead of the usual 6 improves clinical outcomes and quality of life in diffuse midline glioma patients. The treatment's impact on daily living will be assessed through questionnaires.

How Is the Trial Designed?

Group I: Treatment (hypofractionated RT) Experimental Treatment 4 Interventions

Patients undergo hypofractionated RT over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses. Patients undergo MRI and PET-CT scan throughout the study.

Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in European Union as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Hypofractionated radiotherapy (HFRT) for early stage non-small-cell lung cancer (NSCLC) in 26 medically inoperable patients showed a 53.9% overall response rate and a median survival duration of 27.8 months, indicating its efficacy as a treatment option.

The study found that a biologically equivalent dose (BED) greater than 90 Gy was a significant prognostic factor for better progression-free survival and local control, while severe toxicities were not observed, suggesting HFRT is a safe alternative for patients who cannot undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated three-dimensional conformal radiotherapy for medically inoperable early stage non-small-cell lung cancer. Lee, JH., Wu, HG., Kim, HJ., et al.[2021]

In a study of 274 early breast cancer patients treated with hypofractionated radiation treatment (HFRT) over a median follow-up of 7 years, the local recurrence-free survival rate was very high at 97.2%, indicating that HFRT is effective in preventing local cancer recurrence.

The acute toxicity associated with HFRT was generally low, with most patients experiencing less than grade 3 side effects, suggesting that HFRT is a safe treatment option for eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation treatment in early breast cancer: Results in a New Zealand setting. James, ML., Dehn, G., Robinson, BA.[2018]

Hypofractionated stereotactic radiotherapy (HFSRT) is an effective treatment for brain metastases, showing a local control rate of 87.02% when combined with surgery compared to 73.53% with HFSRT alone, based on a study of 389 patients.

Surgery prior to HFSRT significantly improves local control and overall survival, particularly for larger brain metastases (>2.5 cm), highlighting the importance of a multidisciplinary approach in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain metastases treated with hypofractionated stereotactic radiotherapy: 8 years experience after Cyberknife installation. Mengue, L., Bertaut, A., Ngo Mbus, L., et al.[2021]

In a study of 56 breast cancer patients receiving hypofractionated external beam radiotherapy (HFRT) after mastectomy, the treatment was well tolerated with mild to moderate acute skin toxicity, and no severe hematological toxicity was observed, indicating a favorable safety profile.

HFRT effectively delivered targeted doses to the chest wall while minimizing exposure to surrounding organs, with mean lung and heart doses remaining within safe limits, suggesting that HFRT can be a viable option for post-mastectomy radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Study on Dosimetric Outcomes and Acute Toxicity of Post Mastectomy Adjuvant Hypofractionated Radiotherapy for Breast Cancer. Deshmukh, S., Sharan, K., Fernandes, DJ., et al.[2022]

Hypofractionated radiation therapy (HypoRT) was found to be effective in treating inoperable advanced non-small cell lung cancer (NSCLC), with an overall response rate of 83% among 30 patients, and a median follow-up of 13 months.

The treatment was well-tolerated, with manageable acute toxicities; however, 37% of patients experienced locoregional recurrence, and 57% developed distant metastasis, indicating the need for further studies to compare HypoRT with conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image guided hypofractionated 3-dimensional radiation therapy in patients with inoperable advanced stage non-small cell lung cancer. Osti, MF., Agolli, L., Valeriani, M., et al.[2018]

Hypofractionated radiotherapy (HFRT) is being explored as a treatment option for glioblastoma (GBM), particularly in palliative care settings, where it can improve the quality of life for older patients or those with other health issues.

HFRT, especially stereotactic radiosurgery (SRS), is being investigated for both newly diagnosed and recurrent GBM, suggesting it may play an evolving role in treatment strategies alongside standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionation in Glioblastoma: An Overview of Palliative, Definitive, and Exploratory Uses. Jiang, C., Mogilevsky, C., Belal, Z., et al.[2023]

Hypofractionated conformal radiotherapy (hfCRT) effectively achieved an 83% local control rate for brain metastases at one year, indicating its efficacy for treating limited brain metastases.

Tumor size and the extent of surgical resection significantly influenced local control outcomes, with larger lesions (≥2.8 cm) and those treated after subtotal resection showing lower local control rates, suggesting that more aggressive treatment strategies may be needed for these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patients with limited brain metastases treated with hypofractionated (5×6Gy) conformal radiotherapy. Lockney, NA., Wang, DG., Gutin, PH., et al.[2018]

High-dose, hypofractionated radiotherapy (HFRT) demonstrated a high overall response rate of 79% and a one-year local-progression free rate of 50% in treating head-and-neck malignancies, based on a retrospective analysis of 48 patients.

The study found that delivering doses of 6Gray or higher per fraction improved locoregional control, and increased toxicity was not observed with doses of 8Gray or more, suggesting that HFRT can be both effective and safe for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose hypofractionated radiotherapy is effective and safe for tumors in the head-and-neck. Teckie, S., Lok, BH., Rao, S., et al.[2022]

In a study of 463 breast cancer patients, hypofractionated radiotherapy (HFRT) showed a similar rate of locoregional recurrence compared to conventional fractionated radiotherapy (CFRT), with 2.7% recurrence in HFRT versus 4.3% in CFRT.

The 4-year local recurrence-free survival rates were also comparable, with 97% for HFRT and 95% for CFRT, indicating that HFRT is a safe and effective alternative for treating locally advanced breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative retrospective analysis of locoregional recurrence in unselected breast cancer patients treated with conventional versus hypofractionated radiotherapy at a tertiary cancer center? Yadav, R., Lal, P., Agarwal, S., et al.[2022]

Hypofractionated radiation therapy (HFRT) at a dose of 52.5 Gy over 15 fractions was found to be feasible and effective for selected elderly patients with newly diagnosed glioblastoma, showing a median overall survival of 8 months and a 12-month overall survival rate of 30%.

The study indicated that HFRT resulted in limited toxicity, with no increase in steroid use during treatment, and some patients even experienced a reduction in steroid requirements, suggesting a favorable safety profile for this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of hypofractionated radiation therapy in elderly patients with newly diagnosed glioblastoma with poor prognosis. Navarria, P., Pessina, F., Cozzi, L., et al.[2019]

Hypofractionated radiotherapy (HFRT) has emerged as a promising approach for treating glioblastoma (GBM), showing potential for improved survival without significant increases in toxicity, based on a systematic review of studies since 1990.

Combining HFRT with the chemotherapy drug temozolomide (TMZ) suggests a trend towards better survival outcomes, with some studies reporting median survival times of around 20 months, indicating the need for further randomized trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for glioblastoma: strategy for poor-risk patients or hope for the future? Hingorani, M., Colley, WP., Dixit, S., et al.[2021]

In a study of 1,010 breast cancer patients, hypofractionated radiotherapy (HFRT) showed similar locoregional recurrence-free survival (LRRFS) and disease-free survival (DFS) rates compared to conventionally fractionated radiotherapy (CFRT) after a median follow-up of 49.5 months.

While HFRT was effective across various nodal stages and molecular subtypes, it tended to show lower DFS in N2-3 patients with triple-negative breast cancer compared to CFRT, indicating a need for further investigation in this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Practice of Hypofractionated Radiotherapy in Patients With Invasive Breast Cancer. Chen, F., Hui, TSK., Ma, L., et al.[2022]

A hypofractionated radiotherapy (HFRT) schedule of 45.5Gy in 13 fractions was found to be effective for treating grade IV glioblastoma multiforme in 14 elderly patients, with a median overall survival of 7 months.

The treatment was well-tolerated, with no severe skin toxicity and only one case of grade III CNS toxicity, suggesting that this approach could be a safer alternative for elderly patients who cannot undergo longer treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated irradiation for gliomas with 45.5Gy in 13 fractions: a retrospective study. Kouloulias, V., Zygogianni, A., Kouvaris, J., et al.[2018]

In a study of 2309 breast cancer patients, those receiving hypofractionated radiotherapy experienced significantly less acute skin reactions and pain compared to those receiving conventional fractionation, indicating a safer treatment option.

Hypofractionation also resulted in lower levels of patient-reported symptoms like burning, swelling, and fatigue during treatment, suggesting it may enhance patient comfort without compromising long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the Acute Toxic Effects of Breast Radiotherapy by Fractionation Schedule: Comparative Analysis of Physician-Assessed and Patient-Reported Outcomes in a Large Multicenter Cohort. Jagsi, R., Griffith, KA., Boike, TP., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5620204/

Are three weeks hypofractionated radiation therapy (HFRT) ... HFRT consisted of 60 Gy, in daily fractions of 4 Gy given 5 days per week for 3 weeks. The primary endpoints were overall survival (OS), progression free ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1278321825000964

Hypofractionated radiotherapy of central nervous system ... The use of hypofractionated radiotherapy for central nervous system tumours is expanding, particularly due to the increase in reirradiation situations.

3. withpower.com withpower.com/trial/phase-3-glioma-9-2021-581ac

Hypofractionated Radiation Therapy for Brain Cancer This phase II trial studies the clinical outcomes of hypofractionated radiation therapy in patients with diffuse midline gliomas. This study aims to change ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836783

Modified Target Delineation and Moderately ... Although most total dose–escalated radiotherapy regimens showed no significant survival benefit over conventional fractionation (60 Gy in 30 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7498706/

Hypofractionated radiation therapy with temozolomide ... Our results showed that HFRT with concurrent TMZ is a feasible therapeutic approach in patients with GBM, especially those with poor prognostic factors.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10982054/

exploring efficacy and safety - Part 1. Brain and head and neck We aimed to provide a comprehensive summary of the current evidence for HFRT for brain tumors and head and neck cancer and to offer practical recommendations ...

7. cancerblog.mayoclinic.org cancerblog.mayoclinic.org/2023/09/12/5-reasons-brain-tumors-are-still-treated-with-radiation-therapy/

5 reasons brain tumors are still treated with radiation therapy Short-course hypofractionated proton beam therapy incorporating advanced imaging may improve overall survival over standard radiation therapy in ...