Radiosurgery for Patients Recurrent Oligometastatic Disease

Phase II Study of Stereotactic Radiosurgery for Patients With Oligo-recurrent Disease

This study will evaluate the feasibility of radiosurgery for all metastatic sites in patients presenting with oligometastatic disease, defined here as 5 or fewer sites of metastatic disease involving 3 or fewer organ systems.

Study Overview

• Status: Completed
• Conditions: Recurrent Oligometastatic Disease
• Intervention / Treatment: Radiation: Stereotactic Radiosurgery (SRS)

Detailed Description

Death from metastatic cancer is a common cause of death, accounting for 80-90% of cancer deaths. The classic thought process is that metastatic disease represents the continuum such that known metastatic disease is an inevitable harbinger for subsequent metastatic disease. However, it has been reported that a subset of patients with limited volume metastatic disease may have a better prognosis if given aggressive therapy. This group of patients has become known as "oligometastatic". These patients 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. Patients in this study receive SRS/SBRT to all sites of oligometastatic disease.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center - Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Related to Treatment	Adverse Events as measured by CTCAE version 4.0, possibly, probably or definitely related to study treatment.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Functional Assessment of Cancer Therapy - General (FACT-G)	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.	5 years
Overall survival (OS)	The (median) length of time from enrollment to confirmed death from any cause.	Up to 5 years
Serious Adverse Events related to treatment	Serious Adverse Events as measured by CTCAE version 4.0, possibly, probably or definitely related to study treatment.	Up to 5 years
Local control of metastatic sites	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.	Up to 5 years
Analysis of patterns of failure post-SRS/SBRT	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).	Up to 5 years

Collaborators and Investigators

• Sponsor: Steven Burton
• Investigators: Principal Investigator: Steve Burton, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2011
• Primary Completion (Actual): October 13, 2020
• Study Completion (Actual): October 11, 2022

Study Registration Dates

• First Submitted: February 24, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Oligo mets; Oligometastatic disease; Stereotactic Body Radiotherapy (SBRT) (Stereotactic radiosurgery (SRS) plus stereotactic radiotherapy (SRT))
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: HCC 10-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes