Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01345552 : Radiosurgery for Patients Recurrent Oligometastatic Disease
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

3.1 Conditions for Patient Eligibility

3.1.1 Pathologically (histologically or cytologically) proven diagnosis of solid
malignancy 3.1.2 Eligible disease sites include the following

- Breast

- Prostate

- 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)

3.1.3 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 3.1.4
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.

3.1.5 Prior systemic chemotherapy is allowable 3.1.4 Zubrod Performance Status 0-1 3.1.5
Age ? 18 3.1.6 CBC/differential obtained within 4 weeks prior to registration on study,
with adequate bone marrow function defined as follows: 3.1.6.1 Absolute neutrophil count
(ANC) ? 1,800 cells/mm3; 3.1.6.2 Platelets ? 100,000 cells/mm3; 3.1.6.3 Hemoglobin ? 8.0
g/dl (Note: The use of transfusion or other intervention to achieve Hgb ? 8.0 g/dl is
acceptable.); 3.1.7 Women of childbearing potential and male participants must practice
adequate contraception 3.1.8 Patient must provide study specific informed consent prior to
study entry

Exclusion Criteria:

3.2.1 Ineligible disease sites include the following

- Lymphoma

- Leukemia

- Multiple myeloma

- Primary CNS

- Peritoneal carcinomatosis

- Colon cancer with liver-only metastatic disease that is treatable with surgical
resection 3.2.2 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.

3.2.4 Severe, active co-morbidity, defined as follows: 3.2.4.1 Unstable angina and/or
congestive heart failure requiring hospitalization within the last 6 months; 3.2.4.2
Transmural myocardial infarction within the last 6 months; 3.2.4.3 Acute bacterial or
fungal infection requiring intravenous antibiotics at the time of registration; 3.2.4.4
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.

3.2.5 Pregnancy or women of childbearing potential and men who are sexually active and not
willing/able to use medically acceptable forms of contraception; this exclusion is
necessary because the treatment involved in this study may be significantly teratogenic.

3.2.6 Patients unable to have an FDG-PET scan, either through insurance coverage, patient
decision or other reason are not eligible for this study.

3.2.7 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) 3.2.8
Patients unable to have SRS through insurance coverage or ability to pay for SRS
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01345552      |      Link to official Clinicaltrials.gov listing
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