Soft Tissue Sarcomas
Conditions
Keywords
Hypofractionated Radiotherapy
Brief summary
The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.
Detailed description
Study Objectives: Primary: * To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local control * Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and major and minor post-operative complication rates. OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist. GROUP I (ULTRA-HYPOFRACTIONATION \[UH\]): Patients undergo HRT daily for a total of 5 fractions followed by surgery. GROUP II (MODERATE HYPOFRACTIONATION \[MH\]): Patients undergo HRT daily for a total of 15 fractions followed by surgery. After completion of study treatment, patients are followed up within 3 months, then every 3-6 months for a minimum of 2 years.
Interventions
RADIATIONUltra-Hypo-fractionation Radiotherapy
Five fractions of pre-operative radiation
PROCEDUREResection
Surgery
OTHERQuestionnaire Administration
Ancillary studies
RADIATIONModerately-Hypo-fractionation Radiotherapy
15 fractions of pre-operative radiation
Sponsors
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location) * ECOG performance status 0-2 * Patient must be deemed able to comply with radiation treatment and surgery
Exclusion criteria
* History of prior radiation to the same area to be irradiated * Pregnancy * Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local control rate | Approximately 2 years | Will be estimated with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution. The median and a 95% credible interval of the posterior distribution will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | Approximately 2 years | The complication rate will be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study. The complication rate will also be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study. |
Countries
United States
Contacts
Primary ContactVanderbilt-Ingram Service for Timely Access
Outcome results
None listed