Intensity Modulated Proton Radiation for Brain & Spine Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering proton radiation therapy, called Intensity Modulated Proton Radiation Treatment (IMPT), for certain brain and spine cancers. The researchers aim to determine if this technique can more precisely target tumors while preserving healthy tissue, potentially reducing side effects compared to traditional methods. The trial seeks participants with a specific type of tumor in the spine or skull base who have not previously received radiation to the affected area.

As an unphased trial, this study allows patients to contribute to innovative research that could enhance future cancer treatments.

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 prior data suggests that intensity modulated proton radiation treatment (IMPT) is safe for brain and spine cancer?

Research has shown that Intensity Modulated Proton Radiation Treatment (IMPT) reduces radiation exposure to healthy organs compared to other radiation therapies, potentially leading to fewer side effects. For example, one study found that proton therapy, in general, was linked to better survival rates and fewer complications in cancer patients. Proton therapy targets tumors more accurately, helping to protect surrounding healthy tissue. This precision may make IMPT a safer option for patients, possibly reducing the side effects common with standard radiation treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Intensity Modulated Proton Radiation Treatment (IMPT) is unique because it uses precision-targeted proton beams to treat brain and spine cancer, minimizing damage to surrounding healthy tissues. Unlike traditional radiation therapies that often use X-rays, IMPT allows for a high dose to be delivered directly to the tumor with remarkable accuracy. This precision reduces side effects and potentially improves outcomes, which is why researchers are excited about its potential to offer a safer and more effective treatment option for patients with these challenging cancers.

What evidence suggests that intensity modulated proton radiation treatment is effective for brain and spine cancer?

Research has shown that intensity modulated proton radiation treatment (IMPT) holds promise for certain cancers. One study found that when combined with chemotherapy, IMPT led to a complete response in 84% of patients with esophageal cancer, meaning their cancer was no longer detectable. For brain and spine cancers, proton therapy resulted in fewer side effects, such as fatigue, compared to traditional x-ray treatments. Another study found that proton therapy extended patient survival and reduced cancer recurrence compared to other treatments. In this trial, participants will receive high-dose IMPT to evaluate its effectiveness and safety for brain and spine cancers. These findings suggest that IMPT could effectively and safely target tumors while protecting healthy tissue. ^{1 2 3 6 7}

Who Is on the Research Team?

Thomas DeLaney, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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 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) 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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-sarcoma-11-2012-2a8c7

Intensity Modulated Proton Radiation for Brain & Spine ... Intensity-modulated proton therapy (IMPT) combined with chemotherapy showed a high clinical complete response rate of 84% in 19 patients with esophageal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7066950/

Proton therapy for brain tumours in the area of evidence ... Nevertheless, cancer cure rates in HIC currently are near 80% and are on the rise thanks to new advances in medical treatments This leaves many childhood cancer ...

3. emoryproton.com emoryproton.com/cancers-treated/brain-spine-cancer/

Proton Therapy for Brain & Spine Cancer Compared to those assigned to x-rays, patients treated with proton therapy had a statistically lower rate of fatigue (24% vs. 58%) and on average had fewer ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814023898656

Comparing the oncologic outcomes of proton therapy and ... This study of 60,485 patients with HNSCC found that proton therapy was associated with better overall and cancer-specific survival and lower locoregional ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5949408/

Comparison of proton therapy and intensity modulated ... In line with this hypothesis, a recent phase 2 trial comparing stereotactic proton versus photon therapy found that 3-year overall survival was 90% and 27.8%, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03180502

Study Details | NCT03180502 | Proton Beam or Intensity- ... This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6615027/

Intensity Modulated Proton Therapy (IMPT) – The Future of ... Multiple studies published in the past few years have demonstrated the ability of proton therapy, mainly PSPT, to significantly reduce ...