Overview

About this study

Currently, only a few international institutions use CIRT to treat pelvic bone sarcomas. Accordingly, data evaluating the potential differences in oncological outcomes, toxicities, and functional outcomes between CIRT and the more readily accessible local therapies of surgery and PT is scarce. For this reason, we propose conducting a prospective comparative effectiveness study evaluating functional outcomes, toxicities, and local control in patients with pelvic bone sarcomas treated with surgery, PT, and CIRT.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/27/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ivy Petersen, M.D.

Open for enrollment

Contact information:

Kayla Tottingham

(507) 293-1275

Tottingham.Kayla@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Bradford Hoppe, M.D., M.P.H.

Open for enrollment

Contact information:

Kayla Lane M.P.H.

(904) 953-3588

Rodriguez.Kayla1@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jonathan Ashman, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20522276

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