72 Participants Needed

Carbon Ion Therapy vs Surgery vs Proton Therapy for Bone Cancer

Recruiting at 3 trial locations
CT
Overseen ByClinical Trials Referral Office
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which treatment—carbon ion therapy, surgery, or proton therapy (a type of radiation treatment)—best controls pelvic bone sarcomas with the fewest side effects. Researchers seek to assess whether carbon ion therapy can improve quality of life and disease control compared to surgery and proton therapy. Participants will complete quality of life questionnaires and have their medical records reviewed. The trial seeks individuals aged 15 and older, recently diagnosed with specific types of pelvic bone sarcomas, who have not received prior radiation in the area and show no signs of cancer spreading to other parts of the body. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, chemotherapy is allowed according to institutional guidelines, so you may be able to continue some treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that carbon ion therapy is generally safe for treating various types of tumors. Patients experience fewer side effects compared to traditional treatments. This therapy effectively controls tumors and improves survival rates. Reports indicate that any side effects are manageable, and patients tolerate the treatment well.

Proton therapy is another safe option. It targets tumors precisely, helping to protect healthy tissue. Studies have found that proton therapy is as safe as traditional radiation but may cause fewer long-term side effects, making it a promising choice for cancer treatment.

In summary, research has demonstrated that both carbon ion therapy and proton therapy are safe and well-tolerated. These treatments offer promising options with potentially fewer side effects than conventional methods.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for pelvic sarcomas involving the bone because they offer new ways to target and manage the disease. Carbon ion therapy stands out by using heavier ions that can penetrate deeper into tissues, potentially delivering more precise and effective doses to tumors compared to traditional radiation therapies. Proton therapy is also notable for its precision, as it minimizes damage to surrounding healthy tissues by focusing on the tumor itself. Together, these advanced therapies provide options that could improve outcomes and reduce side effects compared to conventional treatments like surgery and standard radiation therapy.

What evidence suggests that this trial's treatments could be effective for pelvic bone sarcomas?

Research has shown that carbon ion therapy effectively treats various tumor types. It controls tumors and increases survival rates while causing fewer side effects. Studies have found that patients receiving carbon ion therapy achieve good results, making it a promising treatment option.

Proton therapy also proves effective. Clinical results indicate it is safe for patients and can improve treatment outcomes. By targeting tumors precisely, it helps protect healthy tissues. Both carbon ion and proton therapies have the potential to control disease better than traditional treatments.

This trial compares these therapies to surgery to determine if they offer improved disease management and quality of life for patients with pelvic bone sarcomas.26789

Who Is on the Research Team?

BS

Bradford S. Hoppe, MD, MPH

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

Males and females >= 15 years of age
Newly diagnosed, histologic confirmation of pelvic chordoma, chondrosarcoma, osteosarcoma, Ewing sarcoma with bone involvement, rhabdomyosarcoma (RMS) with bone involvement or non-RMS soft tissue sarcoma with bone involvement
No evidence of distant sarcoma metastases as determined by clinical examination and any form of imaging
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either carbon ion therapy, surgery, or proton therapy for pelvic sarcomas

Varies by treatment type

Follow-up

Participants complete quality of life questionnaires and are monitored for safety and effectiveness after treatment

Up to 5 years
Annually

What Are the Treatments Tested in This Trial?

Interventions

  • Carbon Ion Therapy
  • Proton Therapy
  • Surgery

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Observational (questionnaires, medical record review)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Cost-Effectiveness of Carbon Ion Radiotherapy in Oncology

In cases of recurrent tumors, CIRT resulted in lower overall treatment costs than comparator therapies. Additionally, CIRT exhibited a favorable ...

Five-Year Survival Outcomes After Carbon-Ion ...

The results revealed that CIRT has a favorable outcome with low toxicity. Age below 77 years was a favorable prognostic factor for OS. Age below ...

Comparison of clinical outcomes between carbon ion ...

CIRT was effective for treating locoregional rectal cancer recurrence, with high rates of local control and survival, and a low late severe toxicity rate.

Carbon Ion Therapy: A Modern Review of an Emerging ...

CIRT represents a promising new treatment technique, with early data suggesting that it is both safe and effective for a variety of tumors.

Estimating the Number of Patients Eligible for Carbon Ion ...

Our study estimated the number of patients eligible for carbon ion radiotherapy in the United States to be 8922 to 89 946 patients, comprising approximately 5% ...

Effectiveness and Safety of Carbon Ion Radiotherapy in ...

CIRT was associated with improved toxicity, local tumor control, OS, and PFS compared to conventional treatments. Therefore, CIRT was found to be a safe and ...

Efficacy and safety of carbon ion radiotherapy for bone ...

The data indicated that carbon ion radiotherapy was safe and effective for bone sarcomas, showing promising results for local control, overall ...

Carbon Ion Radiotherapy Reirradiation for Recurrent ...

Carbon ion reirradiation appears to be a potentially safe and effective reirradiation modality for treating locoregional recurrent malignancies.

Salvage Carbon-Ion Radiation Therapy For Locoregionally ...

Treatment-induced adverse effects and early response to CIRT were both favorable. Longer follow-up is needed to evaluate the long-term outcome ...