Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation
Condition: Oligometastatic Disease
Intervention: Stereotactic Radiosurgery (SRS); Chemotherapy
Intervention description: Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.; Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oligo mets; Radiosurgery; Stereotactic Body Radiotherapy (SBRT) (Stereotactic radiosurgery (SRS) plus stereotactic radiotherapy (SRT))

Summary:

      This study will evaluate the feasibility of radiosurgery for all metastatic sites in patients
      presenting with oligometastatic disease, defined here as 5 or fewer sites of metastatic
      disease involving 3 or fewer organ systems.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pathologically (histologically or cytologically) proven diagnosis of solid malignancy
             within 8 weeks of registration

          2. Eligible disease sites include the following

               -  Breast

               -  Prostate

               -  GI (including colorectal, anal, esophagus, pancreas, gastric with the exception
                  of colon cancer with resectable liver-only lesions)

               -  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. Patients are stage IV (M1) with any combination of T and N with oligometastatic
             disease as defined by 5 or fewer total sites of metastatic disease involving 3 or
             fewer organ systems

        1 Examples of patients eligible for trial

          -  T3N2M1 NSCLC with 1 CNS metastatic lesion, 2 liver lesions, and 1 adrenal lesion.

          -  T4N1M1 colorectal cancer with 1 liver lesion, 4 bone lesions

          -  T3N0M1 gastric cancer with 1 supraclavicular lymph node, 2 liver lesions, and 2 CNS
             lesions 4Metastatic disease sites must be treatable with SRS (at discretion of
             treating physician).

             5Primary disease site must be able to be treated with curative intent 6Zubrod
             Performance Status 0-1 7Age ≥ 18 8CBC/differential obtained within 4 weeks prior to
             registration on study, with adequate bone marrow function defined as follows:

          -  Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;

          -  Platelets ≥ 100,000 cells/mm3;

          -  Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve
             Hgb ≥ 8.0 g/dl is acceptable.); 9Women of childbearing potential and male participants
             must practice adequate contraception 10Patient must provide study specific informed
             consent prior to study entry.

        Exclusion Criteria:

          1. Ineligible disease sites include the following

               -  Lymphoma

               -  Leukemia

               -  Multiple myeloma

               -  Primary CNS

               -  Peritoneal carcinomatosis

               -  Colon cancer with resectable liver-only lesions

          2. Examples of patients ineligible for trial

               -  T1N1M1 NSCLC with 1 CNS lesion, 1 bone lesion, 1 adrenal lesion and a cervical
                  lymph node (4 sites of metastatic disease)

               -  T2N1M1 Gastric cancer with 6 liver lesions (more than 5 sites of metastatic
                  disease)

          3. Other

               -  Lung cancer with pleural effusion (wet IIIB) are not eligible

               -  Recurrent cancers are not eligible

               -  Diffuse metastatic spread confined to one organ system is ineligible; examples of
                  this include leptomeningeal spread in the CNS and peritoneal carcinomatosis.

          4. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
             different cancer is allowable but cannot have any other primary cancer diagnosed or
             treated within the last 3 years other than cutaneous skin cancers. Patient may have
             previous chemotherapy as treatment of this previous malignancy as long as the
             chemotherapy has completed more than 3 years ago.

          5. Prior radiotherapy to the region of the study cancer that would result in overlap of
             radiation therapy fields

          6. 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.

               -  Immuno-compromised patients.

          7. 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.

          8. 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)

          9. Patients unable to have an FDG-PET/CT scan, either through insurance coverage, patient
             decision or other reason are not eligible for this study.

         10. Patients unable to have SRS through insurance coverage or ability to pay for SRS