[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05917301":3,"trial-entities:NCT05917301":128,"trial-summary:NCT05917301":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":73,"minimum_age":74,"maximum_age":17,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":89,"locations":92,"central_contacts":112,"overall_officials":117,"references":122,"see_also_links":127},"NCT05917301","SIB2289","Pre-operative Hypofractionated Proton Therapy","PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma","RECRUITING","2032-12","2026-04","2026-04-17","2024-04-18","Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",true,"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 \u002F quality of life after the procedures.\n\nPatients 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.",null,[19],"Soft Tissue Sarcoma",[21,22,23],"proton therapy","soft tissue sarcoma","hypofractionated","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},40,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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.",[37],"Pre-operative hypofractionated proton therapy",[39],{"measure":40,"description":41,"timeFrame":42},"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",[44,48,52,55,59,63,66,69],{"measure":45,"description":46,"timeFrame":47},"Incidence of acute grade ≥3 adverse events","Rate of acute grade 3 or higher adverse events (CTCAE5)","2 years after treatment",{"measure":49,"description":50,"timeFrame":51},"Rate of local recurrence free survival","Number of patients without local recurrence on CT and\u002For MRI at specified time points.","1 and 2 years after enrollment",{"measure":53,"description":54,"timeFrame":51},"Rate of metastasis free survival","Number of patients without metastasis on CT and\u002For MRI at specified time points.",{"measure":56,"description":57,"timeFrame":58},"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",{"measure":60,"description":61,"timeFrame":62},"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",{"measure":64,"description":65,"timeFrame":62},"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.",{"measure":67,"description":68,"timeFrame":62},"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.",{"measure":70,"description":71,"timeFrame":72},"Rate of pathologic complete response","Pathologic complete response rate is reported as the number of patients who achieve pathologic complete response after treatment.\n\nAs per the NCCN guidelines, pathologic response is graded by the system recommended by the AJCC Cancer Staging Manual and CAP guidelines:\n\nComplete response - no remaining viable cancer cells Moderate response - only small clusters\u002Fsingle cancer cells remain Minimal response - residual cancer remaining, but with predominant fibrosis Poor response - minimal\u002Fno tumor kills, extensive residual cancer","through study conclusion (estimated 5 years from opening)","ALL","18 Years",false,{"inclusion":77,"exclusion":81,"raw_text":88},[78,79,80],"Adult patients (≥18 years of age)","Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma","WHO\u002FECOG status ≤2",[82,83,84,85,86,87],"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.","Inclusion Criteria:\n\n* Adult patients (≥18 years of age)\n* Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma\n* WHO\u002FECOG status ≤2\n\nExclusion Criteria:\n\n* History of prior local radiation therapy\n* Inability to tolerate treatment position for duration of simulation or treatment\n* Tumor originating in retroperitoneal location\n* Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy\n* 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.\n* Confirmed pregnancy.",[90,91],"ADULT","OLDER_ADULT",[93],{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":109},"Sibley Memorial Hospital","Washington D.C.","District of Columbia","20016","United States",[100,105],{"name":101,"role":102,"phone":103,"email":104},"Curtiland Deville, MD","CONTACT","202-537-4788","cdeville@jhmi.edu",{"name":106,"role":102,"phone":107,"email":108},"Dana Kaplin","410-614-3950","dkaplin1@jhmi.edu",{"lat":110,"lon":111},38.89511,-77.03637,[113,114],{"name":101,"role":102,"phone":103,"email":104},{"name":115,"role":102,"email":116},"Ryan Manuel","rmanuel5@jhmi.edu",[118],{"name":119,"affiliation":120,"role":121},"Curtland Deville, MD","Johns Hopkins School of Medicine","PRINCIPAL_INVESTIGATOR",[123],{"pmid":124,"type":125,"citation":126},"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\u002Fs13014-024-02447-0.",[],{"nct_id":4,"conditions":129,"biomarkers":130},[19],[],{"nct_id":4,"found":15,"summary":132,"prompt_version":17},{"design":133,"status":134,"heading":135,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This is an interventional study with a planned enrollment of 40 adult participants. It is designed to evaluate the safety and effectiveness of hypofractionated proton therapy.","completed","Proton Therapy for Soft Tissue Sarcoma","This study is looking at whether hypofractionated proton therapy (a type of radiation treatment given in fewer, larger doses) is safe and effective for adults with soft tissue sarcoma in their arms, legs, or trunk. You would receive five sessions of proton therapy before having surgery for your sarcoma. The main goal is to see how many people have major wound complications after surgery. We're also looking at how well you recover and your quality of life. The study aims to enroll 40 participants, but its current recruitment status is unclear.","Participants will be followed for about two years after surgery, with wound complications measured at 90 days after surgery.",91,"You would receive five sessions of proton therapy before surgery and complete questionnaires about your treatment and quality of life for about two years after surgery. You will also have standard follow-up appointments with your treatment team.","Not stated in the trial record.",[]]