Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas Involving the Bone, the PROSPER Study

  • STATUS
    Recruiting
  • End date
    Aug 30, 2028
  • participants needed
    180
  • sponsor
    Mayo Clinic
Updated on 18 June 2022
cancer chemotherapy
sarcoma
proton therapy
soft tissue sarcoma

Summary

This study compares carbon ion therapy, surgery, and proton therapy to determine if one has better disease control and fewer side effects. There are three types of radiation treatment used for pelvic bone sarcomas: surgery with or without photon/proton therapy, proton therapy alone, and carbon ion therapy alone. The purpose of this study is to compare quality of life among patients treated for pelvic bone sarcomas across the world, and to determine if carbon ion therapy improves quality of life compared to surgery and disease control compared with proton therapy.

Description

PRIMARY OBJECTIVES:

I. Demonstrate whether carbon ion therapy provides improved patient reported health related quality of life (PRO-HRQOL) outcomes and less significant toxicities compared with surgery.

II. Demonstrate whether carbon ion therapy provides improved local control versus proton therapy.

OUTLINE

Patients complete quality of life questionnaires over 20 minutes at baseline (before any therapy), 2-4 and 5-9 months after completion of therapy, and then annually for up to 5 years. Patients' medical records are also reviewed.

Details
Condition Bone Sarcoma, Chondrosarcoma, Chordoma, Ewing Sarcoma of Bone, Pelvic Rhabdomyosarcoma
Treatment quality-of-life assessment, Electronic Health Record Review
Clinical Study IdentifierNCT05033288
SponsorMayo Clinic
Last Modified on18 June 2022

Eligibility

Yes No Not Sure

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
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
Patients capable of childbearing must agree to use adequate contraception
Ability to complete questionnaire(s) by themselves or with assistance
Ability to provide written informed consent
Chemotherapy per institutional guidelines is allowed

Exclusion Criteria

Patients receiving palliative treatment
Recurrent disease
Males and females < 15 years of age
Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be partially or completely encompassed by the radiation volume needed to treat the current sarcoma. In other words, treatment on this study would require re-irradiation of tissues
Patients with distant sarcoma metastases
Benign pelvic bone histologies
Any of the following
Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note