Stereotactic Radiosurgery in Treating Patients with Oligo-Recurrent Disease

Status: Closed to Accrual

Description

This phase II trial studies how well stereotactic radiosurgery works in treating patients with cancer that has come back and has spread to 5 or fewer places in the body (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 * NOTE: fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) scans are required for full staging of metastatic disease prior to enrollment; if subject has had an FDG-PET/computed tomography (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: biopsy does not have to be performed at the time of enrollment for patients with recurrent disease as long as biopsy was performed at time of initial diagnosis
  • Eligible disease sites include the following * Breast * Prostate * Gastrointestinal (GI) (including colorectal, anal, esophagus, pancreas, gastric with the exception of patients with colon cancer and liver-only metastatic disease) * 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) or recurrent with any combination of T and N with oligometastatic disease as defined by 5 or fewer total sites of metastatic disease * NOTE: number of metastatic sites based on most recent imaging studies in order to determine number of oligometastatic sites; for example, if patient initially had 10 sites of metastatic disease, was treated with chemotherapy resulting in complete response of 5 lesions and stable disease of 5 lesions, and no new lesions based on repeat imaging, the patient would be eligible for treatment on protocol
  • Can have recurrent disease from the primary disease (this is definition of oligorecurrent disease) but cannot have any other primary cancer diagnosed or treated within the last 3 years other than cutaneous skin cancer
  • Prior systemic chemotherapy is allowable
  • 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 central nervous system (CNS) * Peritoneal carcinomatosis * Colon cancer with liver-only metastatic disease that is treatable with surgical resection
  • Other * Diffuse metastatic spread confined to one organ system is ineligible; examples of this include leptomeningeal spread in the CNS and peritoneal carcinomatosis. * Metastatic disease sites must be treatable with stereotactic radiosurgery (at discretion of treating physician); patients with oligometastatic sites not amenable to SRS treatment, either through size or locations, are ineligible for this trial
  • 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
  • Patients unable to have an FDG-PET scan, either through insurance coverage, patient decision or other reason are not eligible for this study
  • 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)
  • Patients unable to have SRS/SBRT through insurance coverage or ability to pay for SRS/SBRT

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Phase II study to evaluate feasibility of stereotactic radiation (SRS)/stereotactic body radiation therapy (SBRT) in patients with oligometastatic disease.

SECONDARY OBJECTIVES:

I. Toxicity (as measured by common toxicity criteria version 3).

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

III. Local control of metastatic sites.

IV. Overall survival of patients as compared to historical norms.

V. Analysis of patterns of failure post-SRS/SBRT.

OUTLINE:

Patients undergo SRS/SBRT over 1-2 hours for 5-21 days with the exact fractionation and dose at the discretion of the treating physician. Patients may receive chemotherapy and/or undergo surgery at the discretion of the treating surgeon.

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 10-028
Secondary IDs NCI-2014-01953, REN13120040, UPCI# 10-028
Clinicaltrials.gov ID NCT01345552