Stereotactic Radiosurgery in Treating Patients with Oligometastatic Disease

Status: Active

Description

This phase II trial studies how well stereotactic radiosurgery works in treating patients with cancer that has spread to 5 or fewer places in the body and involves 3 or fewer organs (oligometastatic disease). Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.

Eligibility Criteria

Inclusion Criteria

  • Pathologically (histologically or cytologically) proven diagnosis of solid malignancy within 8 weeks of registration * NOTE: fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scans are required for full staging of metastatic disease; if subject has had an FDG-PET/CT scan within the last 8 weeks, it will not need to be repeated * NOTE: pathological confirmation is not required for all disease sites as long as the sites of metastatic disease are radiographically and clinically consistent with metastatic disease from a known (biopsy proven) primary * NOTE: the primary site does not have to be the site of pathological confirmation; for example, in a patient with a radiographic lung lesion with mediastinal lymphadenopathy and a liver lesion, a liver biopsy which is constant with lung primary would preclude the necessity for further pathologic diagnosis
  • Eligible disease sites include the following * Breast * Prostate * Gastrointestinal (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)
  • 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 * Examples of patients eligible for trial ** T3N2M1 non-small cell lung cancer (NSCLC) with 1 central nervous system (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
  • Metastatic disease sites must be treatable with SRS (at discretion of treating physician)
  • Primary disease site must be able to be treated with curative intent
  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Women of childbearing potential and male participants must practice adequate contraception
  • Patient must provide study specific informed consent prior to study entry

Exclusion Criteria

  • Ineligible disease sites include the following * Lymphoma * Leukemia * Multiple myeloma * Primary CNS * Peritoneal carcinomatosis * Colon cancer with resectable liver-only lesions
  • 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)
  • 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
  • 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
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • 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
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Oligometastatic disease sites not eligible: * Trachea involvement (direct invasion, tumors close to or abutting trachea are eligible) * Heart (direct invasion or involvement, pericardial lymph nodes can be treated)
  • Patients unable to have an FDG-PET/CT scan, either through insurance coverage, patient decision or other reason are not eligible for this study
  • Patients unable to have SRS/SBRT through insurance coverage or ability to pay for SRS/SBRT

Locations & Contacts

Pennsylvania

Erie
The Regional Cancer Center
Status: Active
Contact: Raymond Bernard Wynn
Phone: 724-983-7570
Email: wynnrb@upmc.edu
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: Dwight Earl Heron
Phone: 412-623-6720
Email: HeronD2@upmc.edu
UPMC-Shadyside Hospital
Status: Active
Contact: Steven A. Burton
Phone: 412-623-6720
Email: burtons@upmc.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Phase II study to evaluate feasibility of curative treatment approach to patients presenting with oligometastatic disease.

SECONDARY OBJECTIVES:

I. Quality of life (as measured by the Functional Assessment of Cancer Therapy [FACT] quality of life surveys).

II. Local control of metastatic sites.

III. Local control of primary site.

IV. Overall survival of patients.

V. Subsequent sites of failure and time to failure.

OUTLINE:

METASTATIC DISEASE TREATMENT: Patients undergo stereotactic radiosurgery (SRS)/stereotactic body radiation therapy (SBRT) over approximately 1-2 hours with the exact fractionation and dose at the discretion of the treating physician.

PRIMARY DISEASE TREATMENT: After completion of SRS/SBRT* (within 6 weeks), patients undergo surgery, receive chemotherapy, receive radiation therapy, or a combination of all three at the discretion of the treating physician.

* NOTE: In some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 3 years, and then every 6 months thereafter.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
UPMC-Shadyside Hospital

Principal Investigator
Steven A. Burton

Trial IDs

Primary ID 10-027
Secondary IDs NCI-2014-01952, UPCI #10-027, REN13120042
Clinicaltrials.gov ID NCT01345539