Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation

Patients with oligometastatic disease (defined here as 5 or fewer sites of metastatic disease
involving 3 or fewer organ systems) are potentially curable with stereotactic radiosurgery
(SRS) or stereotactic radiotherapy (SRT) (collectively referred to as stereotactic body
radiotherapy or SBRT) to the metastatic disease sites in combination with standard curative
therapy to the primary site.

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