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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00335181 | Other Identifier | Johns Hopkins Medicine |
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| Name | Class |
|---|---|
| Robert L. Sloan Fund for Cancer Research | OTHER |
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This study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes / quality of life after the procedures.
Patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-operative hypofractionated proton therapy | Experimental | Patients will have 5 fractions of proton therapy prior to surgical resection of their sarcoma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypofractionation | Radiation | This study is being done to see if hypofractionation in treating sarcoma, will also provide patients with a faster and safer treatment outcome. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of major wound complications | Number of major wound complications as defined by the CAN-NCIC-SR2 trial ("secondary operation under general or regional anaesthesia for wound repair (debridement, operative drainage, and secondary wound closure including rotationplasty, free flaps, or skin grafts), or wound management without secondary operation…[including] an invasive procedure without general or regional anaesthesia (mainly aspiration of seroma), readmission for wound care such as intravenous antibiotics, or persistent deep packing for 120 days or longer.") | 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute grade ≥3 adverse events | Rate of acute grade 3 or higher adverse events (CTCAE5) | 2 years after treatment |
| Rate of local recurrence free survival | Number of patients without local recurrence on CT and/or MRI at specified time points. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Curtiland Deville, MD | Contact | 202-537-4788 | cdeville@jhmi.edu | |
| Ryan Manuel | Contact | rmanuel5@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Curtland Deville, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Recruiting | Washington D.C. | District of Columbia | 20016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38745333 | Derived | Gogineni E, Chen H, Hu C, Boudadi K, Engle J, Levine A, Deville C Jr. Prospective phase II trial of preoperative hypofractionated proton therapy for extremity and truncal soft tissue sarcoma: the PRONTO study rationale and design. Radiat Oncol. 2024 May 14;19(1):56. doi: 10.1186/s13014-024-02447-0. |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| 1 and 2 years after enrollment |
| Rate of metastasis free survival | Number of patients without metastasis on CT and/or MRI at specified time points. | 1 and 2 years after enrollment |
| Rate of late grade ≥2 radiation toxicity | Rate of grade 2 or higher CTCAE5 adverse events associated with radiation therapy (fibrosis, lymphedema, or joint stiffness). | median two year follow up |
| Musculoskeletal Tumor Rating Scale scores | The Musculoskeletal Tumor Rating Scale measures physical function in patients with musculoskeletal tumors. The total score for the MSTS ranges 0-30 with higher scores indicating better function. | baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years |
| Toronto Extremity Salvage Score (TESS) scores | The Toronto Extremity Salvage Score (TESS) measures physical function in patients with musculoskeletal tumors. The total score for the TESS ranges 0-100 with higher scores indicating better function. | baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years |
| Functional Assessment of Cancer Therapy-General (FACT-G) scores | The Functional Assessment of Cancer Therapy-General (FACT-G) measures quality of life for patients with cancer. The total score for the FACT-G ranges 0-108 with higher scores indicating better function. | baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years |
| Rate of pathologic complete response | Pathologic complete response rate is reported as the number of patients who achieve pathologic complete response after treatment. As per the NCCN guidelines, pathologic response is graded by the system recommended by the AJCC Cancer Staging Manual and CAP guidelines: Complete response - no remaining viable cancer cells Moderate response - only small clusters/single cancer cells remain Minimal response - residual cancer remaining, but with predominant fibrosis Poor response - minimal/no tumor kills, extensive residual cancer | through study conclusion (estimated 5 years from opening) |