Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation

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:
NCT01345539
First received: February 17, 2011
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
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 for Curative Intent Treatment for Patients With Oligometastatic Disease at Initial Presentation (UPCI #10-027)

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Feasibility of SRS/SBRT in patients with metastatic disease at initial presentation [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
    Being able to complete accrual to study


Secondary Outcome Measures:
  • Quality of life (as measured by FACT surveys) [ 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

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

  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • Analysis of patterns of failure post-SRS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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


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, 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01345539

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: 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
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: NCT01345539     History of Changes
Other Study ID Numbers: 10-027
Study First Received: February 17, 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 14, 2014