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Radiosurgery for Patients Recurrent Oligometastatic Disease

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ClinicalTrials.gov Identifier: NCT01345552
Recruitment Status : Active, not recruiting
First Posted : May 2, 2011
Last Update Posted : April 14, 2021
Sponsor:
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) Not Applicable

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)
Actual Enrollment : 174 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 2021
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. Detection of Benefit [ Time Frame: Up to 3 years ]
    Proportion of patients with oligometastatic disease that are able to complete stereotactic radiation (SRS).


Secondary Outcome Measures :
  1. Adverse Events Related to Treatment [ Time Frame: Up to 5 years ]
    Adverse Events as measured by CTCAE version 4.0, possibly, probably or definitely related to study treatment.

  2. The Functional Assessment of Cancer Therapy - General (FACT-G) [ Time Frame: 5 years ]
    A a self-administered, 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Scaling of items: Five-point scale from 0 (not at all) to 4 (very much). Scoring: Subscale scores added to obtain total score. Alternative scoring includes the Trial Outcome Index (TOI), which is the sum of the Physical, Functional, Cancer Subscales. The TOI is reported to be an efficient and precise summary index of physical and functional outcomes. Higher scores indicated better quality of life.

  3. Local disease control [ Time Frame: Up to 5 years ]
    Proportion of patients with local control is defined as stable disease (SD), partial response (PR), or complete response (CR) in the target lesion, per RECIST v1.1. Complete Response (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

  4. Overall survival (OS) [ Time Frame: Up to 5 years ]
    The (median) length of time from enrollment to confirmed death from any cause.

  5. Local failure [ Time Frame: Up to 5 years ]
    Proportion of patients with local failure (progressive disease (PD) within the target lesion. Per RECIST v1.1: Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).



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

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: 3.1.6.1 Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3; 3.1.6.2 Platelets ≥ 100,000 cells/mm3; 3.1.6.3 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: 3.2.4.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; 3.2.4.2 Transmural myocardial infarction within the last 6 months; 3.2.4.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; 3.2.4.4 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 ClinicalTrials.gov identifier (NCT number): NCT01345552


Locations
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United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Steven Burton
Investigators
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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
ClinicalTrials.gov Identifier: NCT01345552    
Other Study ID Numbers: 10-028
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Steven Burton, University of Pittsburgh:
Oligo mets
Oligometastatic disease