Intensity-Modulated Radiation Therapy for Brain Tumor

Recruiting in Palo Alto (17 mi)

Overseen by Wenyin Shi

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Disqualifiers: Diabetes, Smoking, Pregnancy, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well intensity-modulated stereotactic radiation therapy works in treating patients with grade II-IV glioma. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

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 data supports the effectiveness of the treatment Intensity-Modulated Radiation Therapy for Brain Tumor?

Research shows that stereotactic radiotherapy, including its various forms like SRS and SBRT, is a recommended treatment for different types of tumors and conditions, indicating its effectiveness. Additionally, intensity-modulated radiotherapy (IMRT) is known to deliver precise radiation doses to tumors while sparing healthy tissue, which can improve quality of life compared to older methods. ^{1 2 3 4 5}

Is Intensity-Modulated Radiation Therapy (IMRT) generally safe for humans?

Research shows that while Intensity-Modulated Radiation Therapy (IMRT) and related techniques like Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) are commonly used and considered safe, they can have immediate side effects and acute toxicities, especially with repeated sessions. Safety guidelines and quality requirements are in place to minimize risks and ensure patient safety. ^{1 5 6 7 8}

How is Intensity-Modulated Radiation Therapy (IMRT) different from other treatments for brain tumors?

Intensity-Modulated Radiation Therapy (IMRT) is unique because it can precisely target brain tumors while minimizing damage to surrounding healthy tissue, which is especially important for tumors near sensitive areas. This precision is achieved by using multiple angles and fields to focus the radiation dose, potentially improving treatment outcomes compared to conventional methods. ^{1 2 4 9 10}

Research Team

Wenyin Shi

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Intensity-Modulated Stereotactic Radiation Therapy (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.

Participant Groups

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 Canada, Japan for the following indications:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia, PA

Who Is Running the Clinical Trial?

Sidney Kimmel Cancer Center at Thomas Jefferson University

Lead Sponsor

Trials

164

Patients Recruited

10,900+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Definition and quality requirements for stereotactic radiotherapy: consensus statement from the DEGRO/DGMP Working Group Stereotactic Radiotherapy and Radiosurgery. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Does intensity-modulated stereotactic radiotherapy achieve superior target conformity than conventional stereotactic radiotherapy in different intracranial tumours? [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Intensity-modulated stereotactic radiotherapy vs. stereotactic conformal radiotherapy for the treatment of meningioma located predominantly in the skull base. [2022]

4. Netherlands 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? [2022]

5. France pubmed.ncbi.nlm.nih.gov

Toxicity and time lapse between immunotherapy and stereotactic radiotherapy of brain metastases. [2021]

6. England 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Immediate side effects of stereotactic radiotherapy and radiosurgery. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: An ASTRO Safety White Paper Update. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of intensity-modulated tomotherapy with stereotactically guided conformal radiotherapy for brain tumors. [2019]