PRONTO: Pre-operative Hypofractionated Proton Therapy
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pre-operative hypofractionated proton therapy Patients will have 5 fractions of proton therapy prior to surgical resection of their sarcoma. |
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.
|
Outcome Measures
Primary Outcome Measures
- Rate of major wound complications [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.")
Secondary Outcome Measures
- Incidence of acute grade ≥3 adverse events [2 years after treatment]
Rate of acute grade 3 or higher adverse events (CTCAE5)
- Rate of local recurrence free survival [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 [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 [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 [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 [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 [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 [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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sibley Memorial Hospital | Washington | District of Columbia | United States | 20016 |
Sponsors and Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
- Principal Investigator: Curtland Deville, MD, Johns Hopkins School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SIB2289
- IRB00335181