Clinical trial NCT01949506: (SBRT) and (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
Official title: Pilot Study Evaluating Stereotactic Body Radiation Therapy (SBRT) and Adaptive Radiation Therapy (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage IV Adult Soft Tissue Sarcoma
Sarcoma,Soft Tissue
Keywords: Lung metastases
Radiation Therapy
Stereotactic Body Radiation Therapy
Sarcoma
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 9
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 is a prospective study to document the local control rates with SBRT specifically for pulmonary metastases from soft tissue sarcoma. This study will prospectively document acute and late toxicity, quality of life (QoL), tumor control, and survival.

Detailed description: A total of no more than 20 people are expected to participate in this study at the Medical College of Wisconsin/Froedtert Hospital. Patients will be followed for three years.

The usual treatment for sarcomas that spread to the lungs is to remove the cancer with surgery. Patients who cannot have surgery or prefer not to have surgery, can receive radiation therapy. Standard radiation therapy involves several weeks of daily treatment sessions, although it is not as effective as surgery and may seriously damage normal surrounding lung tissue. Stereotactic body radiation therapy (SBRT) is a radiation treatment that gives fewer but higher doses of radiation than standard radiation. SBRT is used to treat metastases to the lung from many types of cancer but has not been used very often with patients who have metastatic disease to their lungs from sarcomas.

The purpose of this study is to test the possibility of SBRT to the lung for metastatic disease to the lung. This information will be used to find out if there are factors that can predict recovery or outcome of patients with metastatic disease to the lung from sarcoma. SBRT will consist of 1 to 3 treatments per week for a total of 3 to 5 treatments to each tumor until therapy is complete. After SBRT is completed, follow-up exams will occur 4-6 weeks from the completion of radiation treatment, every 3 months in year 1 and every 6 months for 2 years.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Pathologic confirmation of primary soft tissue sarcoma with pathologic or radiographic evidence of pulmonary metastatic disease
* No evidence of extra pulmonary progression of disease for 3 months prior to enrollment on study
* 1-5 pulmonary lesions all ≤5 cm in size
* Medically inoperable or declines surgery
* Patients may have had previous treatment for pulmonary metastases

Exclusion Criteria:

* Patients who have uncontrolled extra-pulmonary disease
* Pregnant women
* Patients who have greater than 5 pulmonary lesions at the time of study enrollment
* Patients who have disease progression outside the lungs within 3 months of enrollment on the study
* Disease pathology other than sarcoma subtypes
* Patients with a history of metastatic disease from a primary other than sarcoma

Primary outcomes:
measure: Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria.
timeFrame: 6 weeks post SBRT
Secondary outcomes:
measure: Number of Subjects Experiencing Locoregional Recurrences.
timeFrame: 3 years
Other outcomes:
measure: Quality of Life Questionnaire Score
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months, and 36 months
measure: Overall Survival
timeFrame: 3 years
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Manpreet Bedi, MD
role: PRINCIPAL_INVESTIGATOR
References: