Intensity Modulated Proton Radiation for Brain & Spine Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Investigational agents, Antiretrovirals

Disqualifiers: Metastases, Neuromuscular malfunction, Uncontrolled illness, others

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

Compensation: Varies

Number of Visits: 6

64 Participants Needed

Trial Summary

What is the purpose of this trial?

There are two types of external radiation treatments; proton beam and photon beam radiation. What type of therapy participants will receive will depend upon the location of their tumor. Standard treatment would involve receiving either proton or photon radiation delivered by a three dimensional (3-D) conformal radiation technique. 3-D conformal radiation therapy is a technique where the beams of radiation used in the treatment are shaped to match the tumor in order to avoid damaging the healthy surrounding tissue. Standard treatment also may include photon radiation delivered by intensity modulated (IMRT) technique. In this research study we are using an investigational technique to deliver proton radiation therapy called intensity modulated proton radiation treatment (IMPT) which is used to target cancer while sparing healthy tissue. With IMPT (and standard IMRT), radiation intensity can be turned down during the treatment. This control over the intensity of the radiation dose has the potential to provide accuracy and allows us to more safely increase the amount of radiation delivered to the tumor. This accuracy may potentially reduce side effects that patients would normally experience with 3-D proton radiation therapy. Surgery is often an important component of the treatment for these tumors and may be integrated with the IMPT.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, prior chemotherapy is allowed within 30 days of starting treatment, and you cannot be on other investigational agents.

What data supports the effectiveness of the treatment Intensity Modulated Proton Radiation Treatment (IMPT) for brain and spine cancer?

Research shows that Intensity Modulated Proton Therapy (IMPT) can precisely target tumors while sparing nearby healthy tissues, which is beneficial in treating cancers near critical structures, like those in the head and neck. This suggests potential effectiveness for brain and spine cancers, where precision is crucial. ^{1 2 3 4 5}

Is Intensity Modulated Proton Radiation Treatment (IMPT) generally safe for humans?

Intensity Modulated Proton Radiation Treatment (IMPT) has been studied for various cancers, including head and neck, lung, pancreas, and nasopharyngeal cancers. Research suggests that IMPT can reduce radiation exposure to normal organs compared to other radiation therapies, potentially leading to fewer side effects. Initial clinical experiences indicate that it is generally safe, with ongoing studies to further evaluate its safety profile. ^{2 6 7 8 9}

How is Intensity Modulated Proton Radiation Treatment (IMPT) different from other treatments for brain and spine cancer?

Intensity Modulated Proton Radiation Treatment (IMPT) is unique because it allows precise targeting of tumors by adjusting the radiation beam's position, intensity, and depth, which helps protect nearby healthy tissues. This precision is particularly beneficial for complex areas like the brain and spine, where avoiding damage to surrounding critical structures is crucial. ^{1 2 3 5 10}

Research Team

Thomas DeLaney, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with chondrosarcoma or chordoma of the spine, sacrum, or base of skull. Candidates should not have had prior radiation in the affected area but may have had chemotherapy. They must be physically able to participate (ECOG 0-2), without distant metastasis, and agree to use contraception. Excluded are those with other cancers (unless disease-free for 5+ years or specific low-risk cases), brainstem/cord malfunction not caused by the tumor, uncontrolled illnesses, high radiation sensitivity conditions, pregnancy, or HIV on antiretrovirals.

Inclusion Criteria

I haven't had radiation on my skull base, spine, or sacrum but may have had chemotherapy recently.

My organs and bone marrow are functioning normally.

I agree to use birth control during the study.

Exclusion Criteria

My cancer has spread to other parts of my body.

I do not have any severe illnesses or conditions that would interfere with the study.

I have neurological issues not caused by my tumor's growth or its metabolic effects.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive daily high dose intensity modulated proton radiation treatment, Monday through Friday

6-8 weeks

Daily visits (in-person)

Surgical Resection

Participants may undergo surgical resection of the tumor either before or after radiation treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 years

6 weeks after treatment, 6 months after treatment, every 6 months for 4 years, then annually

Treatment Details

Interventions

• Intensity Modulated Proton Radiation Treatment (IMPT)
• Surgical Resection

Trial Overview The study tests intensity modulated proton radiation treatment (IMPT) versus standard therapies like photon beam radiation. IMPT aims to target cancer more precisely while sparing healthy tissue and potentially reducing side effects compared to conventional methods. Participants will receive either IMPT alone or combined with surgical resection depending on their individual case.

Participant Groups

Group I: IMPT Experimental Treatment 1 Intervention

High dose IMPT

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Findings from Research

Intensity-modulated proton therapy (IMPT) combined with chemotherapy showed a high clinical complete response rate of 84% in 19 patients with esophageal carcinoma, indicating its efficacy in treating this type of cancer.

With a median follow-up of 17 months, patients experienced a median overall survival of 39.2 months, and the treatment was associated with acceptable levels of acute toxicity, primarily esophagitis and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of intensity modulated proton therapy and concurrent chemotherapy in esophageal carcinoma: a single institutional experience. Prayongrat, A., Xu, C., Li, H., et al.[2022]

Proton radiation therapy, particularly intensity-modulated proton therapy (IMPT), offers better dose localization compared to conventional photon radiation therapy, potentially reducing damage to surrounding healthy tissues in patients with head and neck and skull base tumors.

Initial clinical experiences suggest that IMPT may lead to fewer acute and long-term toxicities, and ongoing multi-institutional trials aim to further establish its effectiveness in treating these complex tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton radiation therapy for head and neck cancer. Chan, AW., Liebsch, NJ.[2018]

Intensity modulated proton therapy (IMPT) significantly reduces the radiation dose to the hippocampus compared to volumetric modulated arc therapy (VMAT), with pediatric patients receiving a mean dose reduction from 13.7 Gy to 5.4 GyE and adults from 11.7 Gy to 4.4 GyE.

IMPT maintains equivalent target coverage while improving dose homogeneity, suggesting it may provide better protection for sensitive brain structures during whole brain radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages of intensity modulated proton therapy during hippocampal avoidance whole brain radiation therapy. Stoker, J., Vora, S., Patel, A., et al.[2022]

Intensity-modulated photon radiotherapy (IMRT) provided better dose conformity to the prostate cancer target compared to three-dimensional conformal proton therapy (3D-CPT), while both methods effectively delivered the prescribed dose to at least 98% of the target volume.

Proton therapy, particularly with optimized configurations, significantly reduced radiation exposure to the bladder and rectum at lower doses, indicating a potential advantage in sparing healthy tissues during prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy treatment of early-stage prostate cancer with IMRT and protons: a treatment planning comparison. Trofimov, A., Nguyen, PL., Coen, JJ., et al.[2020]

Intensity modulated proton therapy (IMPT) was successfully used in 34 patients with lung and mediastinal cancers, showing significant improvements in sparing normal tissues compared to both intensity modulated radiation therapy (IMRT) and passive scattering proton therapy (PSPT).

IMPT achieved lower doses to critical organs like the lungs and heart while maintaining higher doses to the tumor, demonstrating effective motion management and robust treatment planning through advanced 4D CT simulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implementation of intensity modulated proton therapy for thoracic malignancies. Chang, JY., Li, H., Zhu, XR., et al.[2022]

Intensity modulated proton therapy (IMPT) demonstrated a high local control rate of 94% and an overall survival rate of 78% in a study of 37 patients with hepatocellular carcinoma (HCC) over a median follow-up of 21 months.

The treatment was found to be safe, with only 3% of patients experiencing significant acute toxicity, and 16% showing a minor increase in liver function scores, indicating that IMPT is a feasible option for HCC management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity Modulated Proton Therapy for Hepatocellular Carcinoma: Initial Clinical Experience. Bhangoo, RS., Mullikin, TC., Ashman, JB., et al.[2022]

In a study of 163 patients with Stage III non-small cell lung cancer (NSCLC), intensity-modulated proton therapy (IMPT) significantly reduced the risk of severe pneumonitis and cardiac events compared to intensity-modulated radiation therapy (IMRT).

IMPT demonstrated better dosimetric sparing of the lungs and heart without compromising overall survival or tumor control, making it a potentially safer treatment option for patients with poor pre-treatment lung function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Toxicity Following Intensity-Modulated Proton Therapy (IMPT) Versus Intensity-Modulated Radiation Therapy (IMRT) for Stage III Non-Small Cell Lung Cancer. Yu, NY., DeWees, TA., Voss, MM., et al.[2023]

Pencil-beam scanning intensity modulated proton therapy (IMPT) for localized pancreatic cancer showed significant reductions in radiation exposure to surrounding organs at risk, such as the small bowel and liver, compared to volumetric modulated arc therapy (VMAT).

No patients experienced severe (grade ≥3) treatment-related adverse events, and there was no significant change in health-related quality of life scores during treatment, indicating that IMPT is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with intensity modulated proton therapy for intact, clinically localized pancreas cancer: Clinical implementation, dosimetric analysis, acute treatment-related adverse events, and patient-reported outcomes. Jethwa, KR., Tryggestad, EJ., Whitaker, TJ., et al.[2022]

Intensity-modulated proton therapy (IMPT) showed significant dosimetric advantages over intensity-modulated radiotherapy (IMRT) in sparing adjacent organs at risk (OAR) in 15 out of 29 OAR for 10 patients with nasopharyngeal carcinoma.

With a median follow-up of 24.5 months, IMPT achieved a 100% locoregional control rate and an 88.9% overall survival rate, suggesting excellent clinical outcomes that warrant further investigation into potential reductions in toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated proton therapy for nasopharyngeal carcinoma: Decreased radiation dose to normal structures and encouraging clinical outcomes. Lewis, GD., Holliday, EB., Kocak-Uzel, E., et al.[2022]

In a study of 17 pediatric patients treated with proton beam radiation for intracranial ependymoma, the median follow-up showed promising outcomes with local control at 86%, progression-free survival at 80%, and overall survival at 89%.

Proton therapy demonstrated significant advantages over intensity-modulated radiation therapy (IMRT) by providing similar tumor coverage while sparing more normal tissue, and intensity-modulated proton therapy (IMPT) may further enhance this sparing of critical structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton radiotherapy for childhood ependymoma: initial clinical outcomes and dose comparisons. MacDonald, SM., Safai, S., Trofimov, A., et al.[2022]

References

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

Clinical outcomes of intensity modulated proton therapy and concurrent chemotherapy in esophageal carcinoma: a single institutional experience. [2022]

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

Proton radiation therapy for head and neck cancer. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Advantages of intensity modulated proton therapy during hippocampal avoidance whole brain radiation therapy. [2022]

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

Radiotherapy treatment of early-stage prostate cancer with IMRT and protons: a treatment planning comparison. [2020]

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

Clinical implementation of intensity modulated proton therapy for thoracic malignancies. [2022]

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

Intensity Modulated Proton Therapy for Hepatocellular Carcinoma: Initial Clinical Experience. [2022]

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

Cardiopulmonary Toxicity Following Intensity-Modulated Proton Therapy (IMPT) Versus Intensity-Modulated Radiation Therapy (IMRT) for Stage III Non-Small Cell Lung Cancer. [2023]

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

Initial experience with intensity modulated proton therapy for intact, clinically localized pancreas cancer: Clinical implementation, dosimetric analysis, acute treatment-related adverse events, and patient-reported outcomes. [2022]

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

Intensity-modulated proton therapy for nasopharyngeal carcinoma: Decreased radiation dose to normal structures and encouraging clinical outcomes. [2022]

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

Proton radiotherapy for childhood ependymoma: initial clinical outcomes and dose comparisons. [2022]