Proton Beam Therapy for Chondrosarcoma

Recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Previous irradiation, Metastatic disease

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 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 35

Duration: 7 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether proton beam therapy, possibly combined with photon beam radiation, can effectively treat chondrosarcoma located at the skull base. Researchers aim to determine both the treatment's effectiveness and its safety for patients. Suitable candidates for this study include those with a confirmed diagnosis of skull base chondrosarcoma, who have undergone surgery to remove as much of the tumor as possible, and have not received prior radiation treatment to this area. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

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.

Is there any evidence suggesting that proton beam therapy is likely to be safe for humans?

Research has shown that proton beam therapy is generally safe for treating certain types of tumors. In one study, patients with chordomas, a type of bone cancer, received high doses of proton therapy, and the study found this treatment to be safe and effective. Another study involving patients with skull base tumors, including chondrosarcomas, also confirmed the safety of proton therapy, with these patients experiencing better survival rates after treatment.

Although randomized data specifically for chondrosarcomas is limited, existing studies suggest that proton therapy is well-tolerated. Common side effects are usually mild, such as skin irritation or fatigue, while serious side effects are less common. This therapy targets tumors with precision, helping to protect the surrounding healthy tissues, which may contribute to its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Proton Beam Therapy is unique because it uses targeted proton particles to deliver radiation directly to the tumor, minimizing damage to surrounding healthy tissues. Unlike traditional radiation therapy, which uses X-rays, proton therapy offers more precision, potentially leading to fewer side effects. Researchers are excited about this treatment for chondrosarcoma because it can deliver higher doses of radiation to the cancer cells while reducing the risk to normal tissues, which is particularly valuable for tumors near critical structures. This precision may improve outcomes and quality of life for patients compared to existing treatments.

What evidence suggests that proton beam therapy might be an effective treatment for chondrosarcoma?

Research shows that proton beam therapy, which participants in this trial will receive, can effectively treat skull base chondrosarcoma, a type of tumor. Studies have found that patients with this tumor have better survival rates when treated with proton therapy. High-dose proton therapy, either alone or with other treatments, has proven safe and effective for similar tumors like chordomas. In a study with 159 patients, high-dose proton therapy significantly helped treat skull base tumors, including chondrosarcomas. Overall, these findings suggest that proton beam therapy holds promise for treating this condition. ^{1 2 4 5 6}

Who Is on the Research Team?

David R. Grosshans

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with a type of bone cancer called chondrosarcoma located at the base of the skull. Participants should have had most of their tumor surgically removed, be able to perform daily activities with minimal assistance (Karnofsky Performance status ≥60), and must provide signed consent. They cannot join if they have cancer spread throughout the body or previous radiation treatment to the skull base.

Inclusion Criteria

I've had a detailed brain scan at M. D. Anderson within the last 3 months.

I've had surgery to remove as much of my skull base tumor as possible.

My cancer is a Grade 1-3 chondrosarcoma located at the base of my skull.

Exclusion Criteria

I have had radiation treatment on the base of my skull.

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive proton beam therapy once a day for about 35 treatments over 7 weeks, possibly combined with photon beam therapy

7 weeks

35 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with annual follow-up visits including MRI scans, blood draws, neuropsychological testing, eye exams, and hearing exams

5 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Proton Beam Therapy

Trial Overview The study is examining how effective proton beam therapy is on its own or combined with photon beam radiation in treating skull base chondrosarcoma. Researchers want to see how well these therapies work and monitor their safety for patients.

How Is the Trial Designed?

Group I: Proton Beam Therapy Experimental Treatment 1 Intervention

Proton Beam Therapy - A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.

Proton Beam Therapy is already approved in United States, European Union, Japan, Canada for the following indications:

Approved in United States as Proton Beam Therapy for:

• Various cancers including prostate, breast, lung, liver, and head and neck cancers

Approved in European Union as Proton Therapy for:

• Various cancers including ocular melanoma, chordomas, chondrosarcomas, and certain pediatric cancers

Approved in Japan as Proton Beam Therapy for:

• Various cancers including prostate, liver, and ocular melanoma

Approved in Canada as Proton Therapy for:

• Various cancers including ocular melanoma and certain pediatric cancers

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study of 64 patients treated with proton beam therapy (PBT) for sinonasal malignancies, there was low incidence of severe toxicities (≥G3), with only one acute case of blurred vision that resolved, and no late severe neurologic toxicities observed.

Patient-reported outcomes indicated significant changes in quality of life during the acute to subacute period, particularly in physical functioning and social aspects, but no chronic issues were noted, suggesting that while patients experienced temporary effects, their long-term quality of life remained stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes, physician-reported toxicities, and treatment outcomes in a modern cohort of patients with sinonasal cancer treated using proton beam therapy. Pasalic, D., Ludmir, EB., Allen, PK., et al.[2021]

In a study of 56 patients receiving proton beam therapy (PBT) for various cancers, no severe (Grade 4 or 5) toxicities were observed, indicating a high safety profile for this treatment method.

The most common adverse effect was Grade 3 hematologic toxicity in 12.5% of patients, which was unlikely related to PBT, suggesting that while the therapy is generally safe, further research is needed to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study to evaluate the safety of the world-first spot-scanning dedicated, small 360-degree gantry, synchrotron-based proton beam therapy system. Nishioka, K., Prayongrat, A., Ono, K., et al.[2019]

Proton beam therapy (PBT) is a safe and effective treatment for hepatocellular carcinoma (HCC) in patients with cirrhosis, with minimal acute toxicity and no significant liver function changes observed six months post-treatment.

In a study of 76 patients, the median progression-free survival was 36 months, and 60% of patients within the Milan criteria achieved a 3-year progression-free survival rate, indicating promising long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial. Bush, DA., Kayali, Z., Grove, R., et al.[2022]

In a study of 266 adult patients with primary brain tumors treated with proton beam therapy (PBT), significant declines in health-related quality of life (HRQoL) were observed, particularly in physical and cognitive functioning, three months post-treatment.

Fatigue and depression were the most common symptoms reported, highlighting the need for effective symptom management strategies and evidence-based guidelines to improve HRQoL for patients undergoing PBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life in patients with primary brain tumors during and three months after treatment with proton beam therapy. Langegård, U., Fransson, P., Bjork-Eriksson, T., et al.[2022]

Proton beam therapy (PBT) shows potential benefits for treating certain cancers, such as pediatric CNS tumors and large ocular melanomas, but current evidence does not support its superiority over traditional photon-based therapies for most other cancer types.

The American Society of Radiation Oncology (ASTRO) recommends further robust clinical trials to better define the appropriate use of PBT, as existing data is insufficient to endorse its routine application in many malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence based review of proton beam therapy: the report of ASTRO's emerging technology committee. Allen, AM., Pawlicki, T., Dong, L., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12488416/

Proton beam radiation therapy vs. photon ... - PubMed Central The one, two, three, four, and five-year survival rates of 95%, 85%, 78%, 73%, and 71% of rhabdomyosarcoma patients in our study are also ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10659847/

Proton Therapy for Skull Base Chondrosarcoma - PMC Studies have shown improved survival in patients with skull base chondrosarcoma who undergo proton therapy. However, there is a lack of randomized data.

3. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00019-8/fulltext

A Prospective Phase I/II Clinical Trial of High-Dose Proton ... Our findings suggest that high-dose proton therapy alone or in combination with IMRT is a safe and effective treatment option for chordomas and ...

4. hopkinsmedicine.org hopkinsmedicine.org/news/articles/2020/10/proton-therapy-case-study-skull-base-tumors

Proton Therapy Case Study—Skull Base Tumors A recent study of 159 patients with skull base chondrosarcomas, confirmed the efficacy of systemic high dose adjuvant proton therapy to achieve ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.31958

The role of dose escalation and proton therapy in ... A retrospective National Cancer Data Base analysis of chondrosarcoma and chordoma shows improved 5-year overall survival associated with the ...

6. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-021-01961-9

Proton therapy with a fixed beamline for skull-base chordomas ... The median follow-up time was 21 months [range, 4 to 52]. The median overall survival (OS) was 40 months. The 1- and 2-year OS was 100%, and the ...