Back to resultsPre-operative Hypofractionated Proton Therapy (PRONTO)
Primary Purpose
Soft Tissue Sarcoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hypofractionation
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring proton therapy, soft tissue sarcoma, hypofractionated
Eligibility Criteria
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.
Sites / Locations
- Sibley Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pre-operative hypofractionated proton therapy
Arm Description
Patients will have 5 fractions of proton therapy prior to surgical resection of their sarcoma.
Outcomes
Primary Outcome Measures
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.")
Secondary Outcome Measures
Incidence of acute grade ≥3 adverse events
Rate of acute grade 3 or higher adverse events (CTCAE5)
Rate of local recurrence free survival
Number of patients without local recurrence on CT and/or MRI at specified time points.
Rate of metastasis free survival
Number of patients without metastasis on CT and/or MRI at specified time points.
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).
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.
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.
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.
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
Full Information
NCT ID
NCT05917301
First Posted
June 1, 2023
Last Updated
July 5, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1. Study Identification
Unique Protocol Identification Number
NCT05917301
Brief Title
Pre-operative Hypofractionated Proton Therapy
Acronym
PRONTO
Official Title
PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2030 (Anticipated)
Study Completion Date
December 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done to see if 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
Keywords
proton therapy, soft tissue sarcoma, hypofractionated
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-operative hypofractionated proton therapy
Arm Type
Experimental
Arm Description
Patients will have 5 fractions of proton therapy prior to surgical resection of their sarcoma.
Intervention Type
Radiation
Intervention Name(s)
hypofractionation
Intervention Description
This study is being done to see if hypofractionation in treating sarcoma, will also provide patients with a faster and safer treatment outcome.
Primary Outcome Measure Information:
Title
Rate of major wound complications
Description
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.")
Time Frame
90 days after surgery
Secondary Outcome Measure Information:
Title
Incidence of acute grade ≥3 adverse events
Description
Rate of acute grade 3 or higher adverse events (CTCAE5)
Time Frame
2 years after treatment
Title
Rate of local recurrence free survival
Description
Number of patients without local recurrence on CT and/or MRI at specified time points.
Time Frame
1 and 2 years after enrollment
Title
Rate of metastasis free survival
Description
Number of patients without metastasis on CT and/or MRI at specified time points.
Time Frame
1 and 2 years after enrollment
Title
Rate of late grade ≥2 radiation toxicity
Description
Rate of grade 2 or higher CTCAE5 adverse events associated with radiation therapy (fibrosis, lymphedema, or joint stiffness).
Time Frame
median two year follow up
Title
Musculoskeletal Tumor Rating Scale scores
Description
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.
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
Title
Toronto Extremity Salvage Score (TESS) scores
Description
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.
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
Title
Functional Assessment of Cancer Therapy-General (FACT-G) scores
Description
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.
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
Title
Rate of pathologic complete response
Description
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
Time Frame
through study conclusion (estimated 5 years from opening)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Curtiland Deville, MD
Phone
202-537-4788
Email
cdeville@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Lowe
Phone
410-955-8652
Email
katielowe@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtland Deville, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Curtiland Deville, MD
Phone
202-537-4788
Email
cdeville@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Dana Kaplin
Phone
410-614-3950
Email
dkaplin1@jhmi.edu
12. IPD Sharing Statement
Learn more about this trial
Pre-operative Hypofractionated Proton Therapy
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