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Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01345539
Recruitment Status : Recruiting
First Posted : May 2, 2011
Last Update Posted : December 9, 2019
Information provided by (Responsible Party):
Steven Burton, University of Pittsburgh

Brief Summary:
The purpose of this study is to evaluate feasibility of radiosurgery for all metastatic sites for patients presenting with oligometastatic disease.

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

Detailed Description:
Patients with oligometastatic disease (defined here as 5 or fewer sites of metastatic disease involving 3 or fewer organ systems) are potentially curable with stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT) (collectively referred to as stereotactic body radiotherapy or SBRT) to the metastatic disease sites in combination with standard curative therapy to the primary site.

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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 for Curative Intent Treatment for Patients With Oligometastatic Disease at Initial Presentation (UPCI #10-027)
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, 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, adrenal, and liver sites were being treated, both lung sites could be treated Monday, Wednesday, and Friday, the liver on Tuesday, Thursday and the following Tuesday, and the adrenal on Monday, Wednesday, Friday of the second week.
Other Names:
  • CyberKnife
  • Trilogy
  • True Beam

Primary Outcome Measures :
  1. Feasibility of SRS/SBRT in patients with metastatic disease at initial presentation [ Time Frame: 3 Years ]
    Being able to complete accrual to study

Secondary Outcome Measures :
  1. Quality of life (as measured by FACT surveys) [ 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'

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

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

  4. Overall survival [ Time Frame: 5 years ]
    Survival rate will be calculated for all the patients and each patient subset respectively by using Kaplan-Meier survival analyses, with survival and event times defined from the day of enrollment until either an event or last follow-up. We can compare these two year survival rates with those from the patients using traditional therapy.

  5. Analysis of patterns of failure post-SRS [ Time Frame: 5 years ]
    Descriptive analysis of location and timing of disease recurrenc. We will also report the entire patient characteristics at initial presentation of oligometastatic disease and characteristics of Long-term (>=2 years) survivors by using descriptive statistics. SAS software will be used for all the data analysis

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:

  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

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): NCT01345539

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Contact: Gregory J Kubicek, MD 4126236720
Contact: Karen D Holeva 412-623-1275

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United States, Pennsylvania
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Sub-Investigator: Dwight E Heron, MD         
Sub-Investigator: Steven Burton, MD         
Sub-Investigator: John Flickinger, MD         
Sub-Investigator: Regiane Andrade, MD         
Sub-Investigator: Yoshio Arai, MD         
Sub-Investigator: Sanjeev Bahri, MD         
Sub-Investigator: Sushil Beriwal, MD         
Sub-Investigator: Neil Christie, MD         
Sub-Investigator: Rodney Landreneau, MD         
Sub-Investigator: James Luketich, MD         
Sub-Investigator: Arjun Pennathur, MD         
Sub-Investigator: Matthew Schuchert, MD         
Sub-Investigator: Joel Greenberger, MD         
Sub-Investigator: Kiran Mehta, MD         
Sub-Investigator: James Mountz, MD, PhD         
Sub-Investigator: Michael Gibson, MD         
Sub-Investigator: James Ohr, DO         
Sponsors and Collaborators
Steven Burton
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Principal Investigator: Gregory J Kubicek, MD University of Pittsburgh
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Responsible Party: Steven Burton, Clinical Associate Professor, University of Pittsburgh Identifier: NCT01345539    
Other Study ID Numbers: 10-027
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Keywords provided by Steven Burton, University of Pittsburgh:
Oligo mets
Oligometastatic disease