Intensity-Modulated Radiation Therapy for Brain Tumor

Overseen By Wenyin Shi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Disqualifiers: Diabetes, Smoking, Pregnancy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for brain tumors called intensity-modulated stereotactic radiation therapy. The researchers aim to determine if this method, which delivers a high dose of radiation directly to the tumor while sparing nearby healthy tissue, is effective for patients with certain types of brain tumors known as gliomas (grades II-IV). It suits those who have undergone surgery for their glioma, can manage daily activities, and have not received prior scalp radiation. Participants will receive this treatment daily over six weeks. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for brain tumors.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that intensity-modulated stereotactic radiation therapy is safe for treating brain tumors?

Research has shown that intensity-modulated stereotactic radiation therapy (IM-SRT) is generally safe for treating brain tumors. This treatment targets the tumor with high doses of radiation while protecting nearby healthy tissue, reducing side effects.

Another study found that using similar techniques in lung cancer patients effectively controlled the tumor with manageable side effects, suggesting that IM-SRT is well-tolerated. Overall, evidence indicates that IM-SRT is a safe option for people with brain tumors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Intensity-Modulated Stereotactic Radiation Therapy (IM-SRT) is unique because it offers a more precise way to target brain tumors while sparing healthy tissue. Traditional radiation methods can affect surrounding healthy brain areas, leading to side effects. IM-SRT uses advanced technology to shape the radiation beams, allowing for higher doses to the tumor with less impact on nearby healthy tissue. Researchers are excited about this treatment as it could improve outcomes and reduce side effects for patients, providing a more tailored and effective approach to treating brain tumors.

What evidence suggests that intensity-modulated stereotactic radiation therapy is effective for treating glioma?

Research has shown that intensity-modulated stereotactic radiation therapy (IM-SRT), the treatment under study in this trial, can effectively treat brain tumors. Studies on similar treatments indicate that about 80% of tumors do not grow back or spread within a year. IM-SRT targets the tumor directly, protecting healthy brain tissue from damage. This method delivers high doses of radiation precisely where needed, reducing harm to surrounding areas. ^{1 2 6 7 8}

Who Is on the Research Team?

Wenyin Shi

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for patients with grade II-IV glioma who have a Karnofsky performance status of 60 or above, meaning they can care for themselves but may not be able to carry out normal activity or do active work. They must have recovered from surgery at least 21 days prior and begin radiation treatment within 3-8 weeks after surgery. Patients with diabetes requiring insulin, current smokers, previous scalp radiation, intolerance to standard radiation, pregnancy, or inability to use contraception are excluded.

Inclusion Criteria

Patients must have recovered from the effects of surgery; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment

Your doctor believes you have at least three more months to live.

Patient must sign a study specific informed consent form

Exclusion Criteria

Karnofsky performance status (KPS) < 60

Prior history of scalp radiation or intolerance to standard course of radiation treatment

You cannot have an MRI scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo intensity-modulated stereotactic radiotherapy (IM-SRT) daily over 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of wound infection, hair loss, and quality of life

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Intensity-Modulated Stereotactic Radiation Therapy

Trial Overview The trial is testing intensity-modulated stereotactic radiation therapy on patients with low to high-grade gliomas (brain tumors). This advanced form of targeted radiotherapy aims to deliver a high dose directly to the tumor while minimizing damage to surrounding healthy tissue.

How Is the Trial Designed?

Group I: Treatment (IM-SRT) Experimental Treatment 2 Interventions

Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.

Intensity-Modulated Stereotactic Radiation Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Intensity-Modulated Stereotactic Radiation Therapy for:

• Grade II-IV glioma
• Brain tumors
• Spinal tumors
• Cancer metastases

Approved in European Union as Intensity-Modulated Stereotactic Radiation Therapy for:

• Grade II-IV glioma
• Brain tumors
• Spinal tumors
• Cancer metastases
• Meningiomas
• Vestibular schwannomas
• Pituitary adenomas

Approved in Canada as Intensity-Modulated Stereotactic Radiation Therapy for:

• Grade II-IV glioma
• Brain tumors
• Spinal tumors
• Cancer metastases

Approved in Japan as Intensity-Modulated Stereotactic Radiation Therapy for:

• Grade II-IV glioma
• Brain tumors
• Spinal tumors
• Cancer metastases

Who Is Running the Clinical Trial?

Sidney Kimmel Cancer Center at Thomas Jefferson University

Lead Sponsor

Trials

164

Recruited

10,900+

Published Research Related to This Trial

Intensity-modulated stereotactic radiotherapy (IMSRT) provides better conformity and coverage for planning target volumes (PTV) compared to stereotactic conformal radiotherapy (SCRT), especially for irregular and multifocal lesions, based on a study of 10 patients.

IMSRT also offers improved sparing of organs at risk (OAR), resulting in lower doses to these critical areas, although it may increase the volume of normal tissue receiving a low dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated stereotactic radiotherapy vs. stereotactic conformal radiotherapy for the treatment of meningioma located predominantly in the skull base. Baumert, BG., Norton, IA., Davis, JB.[2022]

Stereotactic radiotherapy, including SRS, FSRT, and SBRT, is recognized as a guideline-recommended treatment for both malignant and benign tumors, as well as for certain neurological and vascular disorders.

The German Society for Radiation Oncology and the German Society for Medical Physics have established consensus statements outlining the necessary definitions and quality standards for stereotactic radiotherapy to ensure optimal clinical outcomes and treatment quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and quality requirements for stereotactic radiotherapy: consensus statement from the DEGRO/DGMP Working Group Stereotactic Radiotherapy and Radiosurgery. Guckenberger, M., Baus, WW., Blanck, O., et al.[2020]

In a study of 184 patients undergoing 2 to 6 sessions of stereotactic radiation therapy (SRT) for brain metastases, only 36% experienced acute toxicity, primarily mild headaches, with no severe (grade three or four) toxicities reported.

Repeated SRT sessions did not lead to increased acute neurological toxicity or cumulative brain doses comparable to whole-brain radiotherapy (WBRT), indicating that SRT is a safe and well-tolerated option for managing recurrent brain metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicities and cumulative dose to the brain of repeated sessions of stereotactic radiotherapy (SRT) for brain metastases: a retrospective study of 184 patients. Kuntz, L., Le Fèvre, C., Jarnet, D., et al.[2023]

In a study of 78 patients treated with fractionated stereotactic radiation therapy (SRT) or stereotactic radiosurgery (SRS), 35% experienced immediate side effects (ISE), primarily mild, including headaches, dizziness, and seizures.

Dizziness and vertigo were notably common in patients with acoustic neuromas, but no significant relationship was found between the severity of ISE and the radiation doses received, suggesting that while ISE are frequent, they are generally mild and self-limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate side effects of stereotactic radiotherapy and radiosurgery. Werner-Wasik, M., Rudoler, S., Preston, PE., et al.[2022]

In a study of 59 patients with brain metastases from non-small-cell lung cancer and melanoma, the timing between immunotherapy and stereotactic radiotherapy (SRT) did not significantly affect the local control of tumors or the incidence of severe toxicities.

The main predictor of toxicity was tumor volume, with only 5.1% of patients experiencing grade 3 or higher toxicities, indicating that SRT combined with immunotherapy is generally safe regardless of the timing of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity and time lapse between immunotherapy and stereotactic radiotherapy of brain metastases. Cabanie, C., Biau, J., Durando, X., et al.[2021]

Stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) have advanced significantly, necessitating updated best practices for safety and quality assurance due to their complexity and precision in delivering high doses of radiation.

A team-based approach with trained specialists and a comprehensive quality assurance program is essential for the safe and effective implementation of SRS and SBRT, emphasizing that patient safety is a collective responsibility among all stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: An ASTRO Safety White Paper Update. Das, IJ., Dawes, SL., Dominello, MM., et al.[2022]

Intensity-modulated stereotactic radiotherapy (IMSRT), especially with non-coplanar beams, provides better target conformity and reduces radiation exposure to surrounding organs at risk (OARs) compared to conventional stereotactic radiotherapy (SRT) techniques, as shown in a study involving four patients with various brain tumors.

Among the conventional techniques, dynamic conformal arcs (DCA) and static conformal fields (SCF) were found to be comparable in terms of target conformity, but IMSRT consistently outperformed them, particularly for complex tumor shapes, indicating its potential for safer and more effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does intensity-modulated stereotactic radiotherapy achieve superior target conformity than conventional stereotactic radiotherapy in different intracranial tumours? Sharma, SD., Jalali, R., Phurailatpam, RD., et al.[2009]

Intensity-modulated radiotherapy (IMRT) significantly improves quality of life (QoL) for patients with head and neck cancers compared to traditional two-dimensional radiotherapy (2DRT) and three-dimensional conformal radiotherapy (3DCRT), particularly in areas like dry mouth and eating-related difficulties.

The review included 14 studies, highlighting that while IMRT shows promise for enhancing QoL, further prospective randomized studies are needed to confirm its benefits and justify the additional resources required for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy versus conventional and 3D conformal radiotherapy in patients with head and neck cancer: is there a worthwhile quality of life gain? Tribius, S., Bergelt, C.[2022]

Intensity-modulated radiation therapy (IMRT) is an advanced technique that allows for precise targeting of radiation doses to cancerous areas, potentially improving treatment outcomes.

Despite its promise for escalating radiation doses to better target tumors, there are important radiobiological and clinical concerns that need to be addressed to ensure patient safety and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy. Goffman, TE., Glatstein, E.[2019]

The study compared intensity-modulated radiotherapy (IMRT) using the Peacock system with stereotactically guided conformal radiotherapy (SCRT) in five patients with medium-sized convex-shaped brain tumors, finding that IMRT provided slightly better planning target volume (PTV) coverage.

While the doses to organs at risk (OAR) were higher with the Peacock method, all doses remained below clinically acceptable thresholds, indicating that IMRT can be a safe option for treating these tumors, though further improvements in planning methods may enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intensity-modulated tomotherapy with stereotactically guided conformal radiotherapy for brain tumors. Khoo, VS., Oldham, M., Adams, EJ., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3473526/

The developing role for intensity-modulated radiation therapy ... SRS has an established role for treating selected patients with single or multiple brain metastases, with local tumour control rates at 1 year of around 80% and ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK542166/

Stereotactic Radiosurgery (SRS) and Stereotactic Body ... - NCBI Radiation therapy is intended to damage abnormal tissue, eg, neoplastic tumor cells, while causing minimal injury to adjacent normal tissue.

3. ar.iiarjournals.org ar.iiarjournals.org/content/38/11/6041

Technical Advances in Radiation Therapy for Brain Tumors The estimated incidence of the risk for secondary cancer using IMRT for brain tumor treatment is approximately 130/10,000 persons/year (12). Longer follow-up ...

4. oncodaily.com oncodaily.com/oncolibrary/radiotherapy/radiotherapy-for-brain-tumor

Radiotherapy for Brain Tumor: Types, Success Rate, Side ... Brain disease 1-year local control was 80% and 1-year freedom from progression was 53%. The study concluded that this local therapy approach ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850021001223

Cost-Effectiveness of Stereotactic Radiosurgery and ... A 32% and 34% price increase can, respectively, be seen in 5-fraction SBRT with 3-dimensional plan and intensity modulated radiation therapy delivery sessions ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301609007147

Intensity-Modulated Radiotherapy–Based Stereotactic ... Conclusions. Use of IMRT-based delivery of SBRT using restriction of tumor motion in medically inoperable lung cancer demonstrates excellent local control and ...

7. withpower.com withpower.com/trial/intensity-modulated-radiation-therapy-for-brain-tumor-5ffb9

Intensity-Modulated Radiation Therapy for Brain Tumor This phase II trial studies how well intensity-modulated stereotactic radiation therapy works in treating patients with grade II-IV glioma.

8. bcbsm.com bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2047282.pdf

INTENSITY MODULATED RADIATION THERAPY (IMRT) The following therapy is currently being used to treat malignant brain tumors: 3D-CRT. Outcomes. The general outcomes of interest are overall ...