Clinical trial NCT02701153: Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
Official title: Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Adult Soft Tissue Sarcoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Radiological Society of North America
name: Sarcoma Alliance for Research through Collaboration
name: Sarcoma Foundation of America
name: Tower Cancer Research Foundation
First posted: 2016-03-08
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Detailed description: PRIMARY OBJCETIVES:

I. Grade \>= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years.

SECONDARY OBJECTIVES:

I. Evaluate local control, regional control, distant metastasis, progression free survival, and overall survival.

II. Evaluate the functional outcomes as assessed using the musculoskeletal tumor rating scale (MSTS) and the Toronto Extremity Salvage Score (TESS).

III. Collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.

IV. Investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.

OUTLINE:

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

After completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed soft tissue sarcoma of the extremity/trunk
* Intermediate or high grade sarcoma
* Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)
* Recurrent, any grade, no previous radiation therapy
* Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2
* If a woman is of childbearing potential, a negative serum pregnancy test must be documented

Exclusion Criteria:

* Active treatment of a separate malignancy
* History of prior irradiation to the area to be treated
* Pre-operative chemotherapy (post-op acceptable)

Primary outcomes:
measure: Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Distant metastasis
timeFrame: Up to 3 years
measure: Local failure
timeFrame: Up to 3 years
measure: Overall survival
timeFrame: Up to 3 years
measure: Progression free survival
timeFrame: Up to 3 years
measure: Regional failure
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Anusa Kalbasi, MD
role: PRINCIPAL_INVESTIGATOR
References: