Pre-operative Hypofractionated Proton Therapy

Soft Tissue Sarcoma Clinical Trial

— PRONTO  

Official title:

PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917301
• Other study ID #: SIB2289
• Secondary ID: IRB00335181
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2024
• Est. completion date: December 2032

Study information

• Verified date: April 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Curtiland Deville, MD
• Phone: 202-537-4788
• Email: cdeville[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2032
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

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.

Locations

Country	Name	City	State
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Robert L. Sloan Fund for Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Incidence of acute grade =3 adverse events	Rate of acute grade 3 or higher adverse events (CTCAE5)	2 years after treatment
Secondary	Rate of local recurrence free survival	Number of patients without local recurrence on CT and/or MRI at specified time points.	1 and 2 years after enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)