N/A
N=7
A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall
Soft Tissue Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT01819831 ↗Enrolled (actual)
7
Serious AEs
16.7%
Results posted
Aug 2023
Primary outcome: Primary: Late Radiation Toxicities at 2 Years From the Start of Radiation Treatment — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- proton radiation (Radiation); surgery (wide local excision; limb preservation surgery) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Late Radiation Toxicities at 2 Years From the Start of Radiation Treatment |
— | — |
| SECONDARY Grade 3-5 Adverse Events at 6 Months From the Start of Radiation Treatment. |
— | — |
| SECONDARY Patterns of Failure at 6 Months From the Start of Radiation Treatment |
1 | — |
| SECONDARY Patterns of Failure at 6 Months |
0; 1; 5; 5; 6; 0 | — |
| SECONDARY Wound Complication Rates Infection, Dehiscence at 6 Months From the Start of Radiation Treatment. |
1 | — |
| SECONDARY Report of Late Radiation Morbidity at 2 Years |
5 | — |
Summary
When treated with surgery alone, many soft-tissue sarcomas have a high chance of coming back. Radiation therapy is frequently used in addition to surgery to reduce the chances of the sarcoma coming back. However, radiation can have long-term side effects on the normal tissues surrounding the tumor, leading to problems such as swelling, scarring, and joint stiffness.
Recently, there have been advances in the way that radiation therapy can be given. Proton radiation therapy is one of those advances. With proton radiation, it is possible to give radiation over a smaller area surrounding the tumor, resulting in less radiation to the surrounding normal tissues.
The purpose of this study is to determine whether proton radiation decreases the long-term side effects of radiation on normal tissues and if smaller proton radiation fields reduce local recurrence compared to the larger radiation fields that have been used in prior studies.
Eligibility Criteria
Inclusion Criteria
- Histologically proven primary soft tissue sarcoma of the upper extremity (including shoulder), lower extremity (including hip) or body trunk (excluding retroperitoneum).
- No clinical evidence of distant metastatic disease
- Evaluation by surgeon, with documentation that the tumor is resectable
- ECOG performance status 0-1
- For females of childbearing potential, a serum pregnancy test within 4 weeks prior to registration
- Patient must practice adequate contraception
- Adequate bone marrow function
Exclusion Criteria
- Patients with sarcoma of the head, neck, intra-abdominal or retroperitoneal region, hand or foot
- Histopathology demonstrating rhabdomyosarcoma, extraosseous primitive neuroectodermal tumor (PNET), soft tissue Ewing's sarcoma, osteosarcoma, Kaposi's sarcoma, angiosarcoma, aggressive fibromatosis, dermatofibrosarcoma protuberans or chondrosarcoma
- Clinical evidence of regional lymph node or distant metastatic disease
- Prior invasive malignancy (except non-melanomatous skin cancer or early stage prostate cancer) unless disease free for a minimum of 3 years
- Prior radiotherapy to the potential target anatomic region would result in overlap of radiation fields for current sarcoma
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to used medically acceptable forms of contraception
Data sourced from ClinicalTrials.gov (NCT01819831). 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.