Radiosurgery for Patients Recurrent Oligometastatic Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Dwight Heron, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01345552
First received: February 24, 2011
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Recurrent Oligometastatic Disease
Radiation: Stereotactic Radiosurgery (SRS)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Stereotactic Radiosurgery for Patients With Oligo-recurrent Disease (UPCI# 10-028)

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Phase II study to evaluate feasibility of stereotactic radiation (SRS) in patients with oligometastatic disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Being able to complete accrual to study


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

  • Quality of life surveys (as measured by FACT quality of life studies) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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'

  • Local control of metastatic sites [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    CR, PR, PD of treated sites as measured according to RECIST criteria

  • Overall survival of patients as compared to historical norms [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Kaplan-meier overall survival

  • Analysis of patterns of failure post-SRS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Descriptive analysis of location and timing of disease recurrence


Estimated Enrollment: 44
Study Start Date: June 2011
Estimated Study Completion Date: February 2024
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345552

Contacts
Contact: Gregory J Kubicek, MD 4126236720 kubicekg@upmc.edu
Contact: Karen D Holeva 412-623-1275 holevakd@upmc.edu

Locations
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: Yosio 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 Lukitich, 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
Dwight Heron
Investigators
Principal Investigator: Gregory J Kubicek, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Dwight Heron, Vice Chairman of Clinical Affairs, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01345552     History of Changes
Other Study ID Numbers: 10-028
Study First Received: February 24, 2011
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Oligo mets
Oligometastatic disease

ClinicalTrials.gov processed this record on September 16, 2014