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Radiosurgery for Patients Recurrent Oligometastatic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345552
Recruitment Status : Active, not recruiting
First Posted : May 2, 2011
Last Update Posted : August 27, 2020
Information provided by (Responsible Party):
Steven Burton, University of Pittsburgh

Brief Summary:
The purpose of this study is to evaluate feasibility of stereotactic body radiation (SRS) in patients with recurrent oligometastatic disease.

Condition or disease Intervention/treatment Phase
Recurrent Oligometastatic Disease Radiation: Stereotactic Radiosurgery (SRS) Phase 2

Detailed Description:
Patients with limited disease recurrence, known as oligometastatic or oligorecurrent disease (defined here as 5 or fewer sites of metastatic disease) will benefit in terms of overall survival and disease progression from reduced tumor burden and improved local control via radiation to oligometastatic sites.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Stereotactic Radiosurgery for Patients With Oligo-recurrent Disease (UPCI# 10-028)
Study Start Date : June 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2024

Arm Intervention/treatment
SBRT Radiation: Stereotactic Radiosurgery (SRS)
Dose and fractionation will be dependent on the lesion location and lesion size and is up to the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Note that patients can have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met. For example, if two lung lesions, brain, adrenal, and liver sites were being treated both lung sites could be treated Monday, Wednesday, and Friday and the adrenal, liver and brain lesions treated Tuesday, Thursday
Other Names:
  • CyberKnife
  • Trilogy
  • True Beam

Primary Outcome Measures :
  1. Phase II study to evaluate feasibility of stereotactic radiation (SRS) in patients with oligometastatic disease [ Time Frame: 3 years ]
    Being able to complete accrual to study

Secondary Outcome Measures :
  1. Toxicity (as measured by common toxicity criteria version 3) [ Time Frame: 5 years ]
    Descriptive analysis of toxicity as measured by CTC 3.0. All toxicity will be recorded according to type, timing and severity.

  2. Quality of life surveys (as measured by FACT quality of life studies) [ Time Frame: 5 years ]
    Report changes in QOL scores over time. QOL scores before and after treatment will be compared using univarite and multivariate analysis. QOL will be recored as 'improved' or 'non-improved'

  3. Local control of metastatic sites [ Time Frame: 5 years ]
    CR, PR, PD of treated sites as measured according to RECIST criteria

  4. Overall survival of patients as compared to historical norms [ Time Frame: 5 years ]
    Kaplan-meier overall survival

  5. Analysis of patterns of failure post-SRS [ Time Frame: 5 years ]
    Descriptive analysis of location and timing of disease recurrence

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

3.1 Conditions for Patient Eligibility

3.1.1 Pathologically (histologically or cytologically) proven diagnosis of solid malignancy 3.1.2 Eligible disease sites include the following

  • Breast
  • Prostate
  • 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)

3.1.3 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 3.1.4 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.

3.1.5 Prior systemic chemotherapy is allowable 3.1.4 Zubrod Performance Status 0-1 3.1.5 Age ≥ 18 3.1.6 CBC/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.); 3.1.7 Women of childbearing potential and male participants must practice adequate contraception 3.1.8 Patient must provide study specific informed consent prior to study entry

Exclusion Criteria:

3.2.1 Ineligible disease sites include the following

  • Lymphoma
  • Leukemia
  • Multiple myeloma
  • Primary CNS
  • Peritoneal carcinomatosis
  • Colon cancer with liver-only metastatic disease that is treatable with surgical resection 3.2.2 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.

3.2.4 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.

3.2.5 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.

3.2.6 Patients unable to have an FDG-PET scan, either through insurance coverage, patient decision or other reason are not eligible for this study.

3.2.7 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) 3.2.8 Patients unable to have SRS through insurance coverage or ability to pay for SRS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01345552

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United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Steven Burton
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Principal Investigator: Steve Burton, MD University of Pittsburgh
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Responsible Party: Steven Burton, Clinical Associate Professor, University of Pittsburgh Identifier: NCT01345552    
Other Study ID Numbers: 10-028
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Keywords provided by Steven Burton, University of Pittsburgh:
Oligo mets
Oligometastatic disease