Stereotactic Radiosurgery in Treating Patients with Oligo-Recurrent Disease
This phase II trial studies how well stereotactic radiosurgery works in treating patients with cancer that has come back and has spread to 5 or fewer places in the body (oligometastatic disease). Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.
- Pathologically (histologically or cytologically) proven diagnosis of solid malignancy * NOTE: fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) scans are required for full staging of metastatic disease prior to enrollment; if subject has had an FDG-PET/computed tomography (CT) scan within the last 8 weeks, it will not need to be repeated * NOTE: pathological confirmation is not required for all disease sites as long as the sites of metastatic disease are radiographically and clinically consistent with metastatic disease from a known (biopsy proven) primary * NOTE: biopsy does not have to be performed at the time of enrollment for patients with recurrent disease as long as biopsy was performed at time of initial diagnosis
- Eligible disease sites include the following * Breast * Prostate * Gastrointestinal (GI) (including colorectal, anal, esophagus, pancreas, gastric with the exception of patients with colon cancer and liver-only metastatic disease) * Head and neck * Skin (melanoma and squamous cell carcinoma) * Lung (both small cell and non-small cell) * Sarcoma (both soft tissue and bone) * Gynecologic (endometrial, cervical, ovarian, vaginal, vulvar)
- Patients are stage IV (M1) or recurrent with any combination of T and N with oligometastatic disease as defined by 5 or fewer total sites of metastatic disease * NOTE: number of metastatic sites based on most recent imaging studies in order to determine number of oligometastatic sites; for example, if patient initially had 10 sites of metastatic disease, was treated with chemotherapy resulting in complete response of 5 lesions and stable disease of 5 lesions, and no new lesions based on repeat imaging, the patient would be eligible for treatment on protocol
- Can have recurrent disease from the primary disease (this is definition of oligorecurrent disease) but cannot have any other primary cancer diagnosed or treated within the last 3 years other than cutaneous skin cancer
- Prior systemic chemotherapy is allowable
- Zubrod performance status 0-1
- Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
- Platelets >= 100,000 cells/mm^3
- Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
- Women of childbearing potential and male participants must practice adequate contraception
- Patient must provide study specific informed consent prior to study entry
- Ineligible disease sites include the following * Lymphoma * Leukemia * Multiple myeloma * Primary central nervous system (CNS) * Peritoneal carcinomatosis * Colon cancer with liver-only metastatic disease that is treatable with surgical resection
- Other * Diffuse metastatic spread confined to one organ system is ineligible; examples of this include leptomeningeal spread in the CNS and peritoneal carcinomatosis. * Metastatic disease sites must be treatable with stereotactic radiosurgery (at discretion of treating physician); patients with oligometastatic sites not amenable to SRS treatment, either through size or locations, are ineligible for this trial
- Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- Patients unable to have an FDG-PET scan, either through insurance coverage, patient decision or other reason are not eligible for this study
- Oligometastatic disease sites not eligible based on concern for toxicity: * Trachea involvement (direct invasion, tumors close to or abutting trachea are eligible) * Heart (direct invasion or involvement, pericardial lymph nodes can be treated)
- Patients unable to have SRS/SBRT through insurance coverage or ability to pay for SRS/SBRT
Locations & Contacts
Trial Objectives and Outline
I. Phase II study to evaluate feasibility of stereotactic radiation (SRS)/stereotactic body radiation therapy (SBRT) in patients with oligometastatic disease.
I. Toxicity (as measured by common toxicity criteria version 3).
II. Quality of life surveys (as measured by Functional Assessment of Cancer Therapy [FACT] quality of life studies).
III. Local control of metastatic sites.
IV. Overall survival of patients as compared to historical norms.
V. Analysis of patterns of failure post-SRS/SBRT.
Patients undergo SRS/SBRT over 1-2 hours for 5-21 days with the exact fractionation and dose at the discretion of the treating physician. Patients may receive chemotherapy and/or undergo surgery at the discretion of the treating surgeon.
After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 3 years, and then every 6 months thereafter.
Trial Phase & Type
Steven A. Burton
Secondary IDs NCI-2014-01953, REN13120040, UPCI# 10-028
Clinicaltrials.gov ID NCT01345552