Phase II Study for Curative Intent Treatment for Patients With Oligometastatic Disease at Initial Presentation

HCC 10-027

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.

2013-06-07

2022-05-03

2022-10-20

Terminated

Early phase I

24

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

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2023-10-11