Radiosurgery for Patients Recurrent Oligometastatic Disease

NCT01345552 | Completed DMC FDA Device

• 1 other identifier: HCC 10-028
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Oligometastatic Disease

Keywords

Oligo mets; Oligometastatic disease; Stereotactic Body Radiotherapy (SBRT) (Stereotactic radiosurgery (SRS) plus stereotactic radiotherapy (SRT))

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Serious Adverse Events related to treatment

  Up to 5 years

• The Functional Assessment of Cancer Therapy - General (FACT-G)

  5 years

• Local control of metastatic sites

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

• Analysis of patterns of failure post-SRS/SBRT

  Up to 5 years

Study Arms (1)

SBRT

OTHER

Radiation: Stereotactic Radiosurgery (SRS)

Interventions

Stereotactic Radiosurgery (SRS) RADIATION

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

Also known as: CyberKnife, Trilogy, True Beam

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Conditions for Patient Eligibility
• 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)
• 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.
• 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

You may not qualify if:

• 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.
• 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.
• Patients unable to have an FDG-PET scan, either through insurance coverage, patient decision or other reason are not eligible for this study.
• 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

Sponsors & Collaborators

• Steven Burton: lead

Study Sites (1)

UPMC Hillman Cancer Center - Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Snyder Robinson syndrome

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Steve Burton, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: May 2, 2011
• Study Start: June 28, 2011
• Primary Completion: October 13, 2020
• Study Completion: October 11, 2022
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)