Eine randomisierte Phase-III-Studie zur stereotaktischen Strahlentherapie für die Behandlung von 4 bis 10 Metastasen

Radiation: Palliative Radiation;Drug: Chemotherapy;Drug: Immunotherapy;Drug: Hormones;Other: Observation;Radiation: Stereotactic Ablative Radiotherapy

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- Age 18 or older

- Willing to provide informed consent

- Karnofsky performance score greater than 60

- Life expectancy greater than 6 months

- Histologically confirmed malignancy with metastatic disease detected on imaging.
Biopsy of metastasis is preferred, but not required.

- Controlled primary tumor defined as: at least 3 months since original tumor treated
definitively, with no progression at primary site

- Total number of metastases 4-10

- All sites of disease can be safely treated based on a pre-plan

Exclusion Criteria:

- Serious medical comorbidities precluding radiotherapy. These include interstitial lung
disease in patients requiring thoracic radiation, Crohn's disease in patients where
the GI tract will receive radiotherapy, and connective tissue disorders such as lupus
or scleroderma.

- For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or
C)

- Substantial overlap with a previously treated radiation volume. Prior radiotherapy in
general is allowed, as long as the composite plan meets dose constraints herein. For
patients treated with radiation previously, biological effective dose calculations
should be used to equate previous doses to the tolerance doses listed below. All such
cases must be discussed with one of the study PIs.

- Malignant pleural effusion

- Inability to treat all sites of disease

- Any single metastasis greater than 5 cm in size.

- Any brain metastasis greater than 3 cm in size or a total volume of brain metastases
greater than 30 cc.

- Metastasis in the brainstem

- Clinical or radiologic evidence of spinal cord compression

- Dominant brain metastasis requiring surgical decompression

- Metastatic disease that invades any of the following: GI tract (including esophagus,
stomach, small or large bowel), mesenteric lymph nodes, or skin

- Pregnant or lactating women