N/A
N=35
Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall
Soft Tissue Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT02634710 ↗Enrolled (actual)
35
Serious AEs
54.3%
Results posted
Jun 2023
Primary outcome: Primary: Local Disease Control Assessed by Physical Examination — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypofractionated Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Disease Control Assessed by Physical Examination |
— | — |
| PRIMARY Local Disease Control Assessed by Magnetic Resonance Imaging (MRI) |
— | — |
| SECONDARY Musculoskeletal Tumor Rating Scale (MSTS) Score |
29; 28.3; 27.3 | — |
| SECONDARY Disease-free Survival |
32 | — |
| SECONDARY Overall Survival |
32 | — |
| SECONDARY Radiologic Changes Due to Hypofractionated Radiation. |
-16.2 | — |
| SECONDARY Pathologic Changes Due to Hypofractionated Radiation. |
17.5; 20; 50 | — |
| SECONDARY Treatment-related Necrosis and Fibrosis |
4; 4 | — |
Summary
This is a nonrandomized Phase II pilot protocol to determine the feasibility, toxicity and disease control (local control, overall and progression-free survival) using hypofractionated preoperative radiation therapy in patients with primary localized soft tissue sarcomas (STS).
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years of age
- Core needle biopsy obtained
- Pathologic confirmation of primary soft tissue sarcoma of the upper or lower extremity or chest-wall.
- Stage I-III Soft Tissue Sarcoma of the extremity without evidence of metastatic disease
- Medically operable
- No prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
- MRI obtained of the affected extremity or chest-wall
- CT chest acquired to assess distant disease
- Karnofsky Performance Status (KPS) 60 or above
- Informed consent obtained prior to study entry
Exclusion Criteria
- Patients who have metastatic disease
- Pregnant women
- Women of childbearing potential and male participants must practice adequate contraception.
- Disease pathology other than sarcoma subtypes
- Patients with a history of metastatic disease from a primary other than sarcoma
- Patients who cannot undergo MRI as part of pre-treatment or treatment planning process
- STS of non-extremity or chest-wall regions
- Tumor size ≥ 20 cm maximal dimension
Data sourced from ClinicalTrials.gov (NCT02634710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.