Pre-operative Hypofractionated Proton Therapy (PRONTO)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05917301 |
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Recruitment Status :
Recruiting
First Posted : June 23, 2023
Last Update Posted : May 1, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Soft Tissue Sarcoma | Radiation: hypofractionation | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma |
| Actual Study Start Date : | April 18, 2024 |
| Estimated Primary Completion Date : | December 2030 |
| Estimated Study Completion Date : | December 2032 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pre-operative hypofractionated proton therapy
Patients will have 5 fractions of proton therapy prior to surgical resection of their sarcoma.
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Radiation: hypofractionation
This study is being done to see if hypofractionation in treating sarcoma, will also provide patients with a faster and safer treatment outcome. |
- Rate of major wound complications [ Time Frame: 90 days after surgery ]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.")
- Incidence of acute grade ≥3 adverse events [ Time Frame: 2 years after treatment ]Rate of acute grade 3 or higher adverse events (CTCAE5)
- Rate of local recurrence free survival [ Time Frame: 1 and 2 years after enrollment ]Number of patients without local recurrence on CT and/or MRI at specified time points.
- Rate of metastasis free survival [ Time Frame: 1 and 2 years after enrollment ]Number of patients without metastasis on CT and/or MRI at specified time points.
- Rate of late grade ≥2 radiation toxicity [ Time Frame: median two year follow up ]Rate of grade 2 or higher CTCAE5 adverse events associated with radiation therapy (fibrosis, lymphedema, or joint stiffness).
- Musculoskeletal Tumor Rating Scale scores [ Time Frame: 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 ]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.
- Toronto Extremity Salvage Score (TESS) scores [ Time Frame: 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 ]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.
- Functional Assessment of Cancer Therapy-General (FACT-G) scores [ Time Frame: 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 ]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.
- Rate of pathologic complete response [ Time Frame: through study conclusion (estimated 5 years from opening) ]
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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients (≥18 years of age)
- Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma
- WHO/ECOG status ≤2
Exclusion Criteria:
- History of prior local radiation therapy
- Inability to tolerate treatment position for duration of simulation or treatment
- Tumor originating in retroperitoneal location
- Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy
- Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators.
- Confirmed pregnancy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05917301
| Contact: Curtiland Deville, MD | 202-537-4788 | cdeville@jhmi.edu | |
| Contact: Ryan Manuel | rmanuel5@jhmi.edu |
| United States, District of Columbia | |
| Sibley Memorial Hospital | Recruiting |
| Washington, District of Columbia, United States, 20016 | |
| Contact: Curtiland Deville, MD 202-537-4788 cdeville@jhmi.edu | |
| Contact: Dana Kaplin 410-614-3950 dkaplin1@jhmi.edu | |
| Principal Investigator: | Curtland Deville, MD | Johns Hopkins School of Medicine |
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT05917301 |
| Other Study ID Numbers: |
SIB2289 IRB00335181 ( Other Identifier: Johns Hopkins Medicine ) |
| First Posted: | June 23, 2023 Key Record Dates |
| Last Update Posted: | May 1, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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proton therapy soft tissue sarcoma hypofractionated |
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Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |