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

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chondrosarcoma. The safety of this treatment will also be studied.

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.

What data supports the effectiveness of the treatment Proton Beam Therapy for Chondrosarcoma?

Proton Beam Therapy (PBT) is effective for treating chondrosarcomas because it can deliver high doses of radiation safely, especially in challenging areas like the spine, which is difficult with traditional radiation methods. Additionally, PBT has shown benefits over other radiation approaches in treating similar conditions like chordomas, suggesting its potential effectiveness for chondrosarcomas. ^{1 2 3 4 5}

Is proton beam therapy generally safe for humans?

Proton beam therapy (PBT) has been studied for various conditions, and safety data shows that it is generally safe for humans. In a study with 56 patients, no severe (Grade 4 or 5) treatment-related toxicities were observed, and the most common moderate (Grade 3) side effects were not likely related to PBT. However, one patient did experience a bone fracture possibly related to the therapy, indicating that while generally safe, there can be some risks. ^{2 3 6 7 8}

How is Proton Beam Therapy different from other treatments for chondrosarcoma?

Proton Beam Therapy (PBT) is unique because it can deliver high doses of radiation more safely to tumors, especially those near critical structures, due to its precise targeting and lower exit dose compared to traditional photon therapy. This makes it particularly beneficial for treating chondrosarcomas in challenging locations like the spine and skull base. ^{1 2 3 4 9}

Research Team

David R. Grosshans

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

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

The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial. [2022]

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

A prospective clinical trial of proton therapy for chordoma and chondrosarcoma: Feasibility assessment. [2019]

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

High-Dose Proton Beam-Based Radiation Therapy in the Management of Extracranial Chondrosarcomas. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

An evidence based review of proton beam therapy: the report of ASTRO's emerging technology committee. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Proton beam radiotherapy vs. radiofrequency ablation for recurrent hepatocellular carcinoma: A randomized phase III trial. [2022]

6. England 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. [2019]

7. Ireland 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. [2021]

8. England 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. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Proton Therapy for Skull Base Chondrosarcoma. [2023]