Recurrent Oligometastatic DiseaseNCT01345552
Radiosurgery for Patients Recurrent Oligometastatic Disease
A study testing Stereotactic Radiosurgery (SRS) in people with Recurrent Oligometastatic Disease, run by Steven Burton at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Oligometastatic Disease
- What is being tested?
- Stereotactic Radiosurgery (SRS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2011to 11 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 3.2.1 Ineligible disease sites include the following
- Lymphoma
- Leukemia
- Multiple myeloma
- Primary CNS
- Peritoneal carcinomatosis
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center - Radiation Oncology
Pittsburgh, Pennsylvania, 15232
About this study
Official title: 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.
Read the 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.
- Conditions
- Recurrent Oligometastatic Disease
- Being tested
- Stereotactic Radiosurgery (SRS)
- Keywords
- Oligo mets, Oligometastatic disease, Stereotactic Body Radiotherapy (SBRT) (Stereotactic radiosurgery (SRS) plus stereotactic radiotherapy (SRT))
- Medical subject headings
- Snyder Robinson syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Radiosurgery (SRS)Radiation
Also called CyberKnife, Trilogy, True Beam
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
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Other | Not described Receives: Radiation: Stereotactic Radiosurgery (SRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events Related to Treatment
Adverse Events as measured by CTCAE version 4.0, possibly, probably or definitely related to study treatment.
Measured: Up to 5 years
Secondary outcomes (5)
Serious Adverse Events related to treatment
Serious Adverse Events as measured by CTCAE version 4.0, possibly, probably or definitely related to study treatment.
Measured: Up to 5 years
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.
Measured: 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.
Measured: Up to 5 years
Overall survival (OS)
The (median) length of time from enrollment to confirmed death from any cause.
Measured: 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).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study start28 Jun 2011
- Primary completion13 Oct 2020
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Oligometastatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven Burton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven Burton, University of Pittsburgh
- Investigators
- Steve Burton, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345552
- Sponsor's protocol ID
- HCC 10-028
- Status last verified
- May 2023
- First submitted
- 24 Feb 2011
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Stereotactic Radiosurgery for Patients With Oligo-recurrent Disease
- ClinicalTrials.gov ID
- NCT01345552
- Acronym / sponsor ID
- HCC 10-028
- Conditions
- Recurrent Oligometastatic Disease
- Keywords
- Oligo mets, Oligometastatic disease, Stereotactic Body Radiotherapy (SBRT) (Stereotactic radiosurgery (SRS) plus stereotactic radiotherapy (SRT))
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Steven BurtonUniversity, hospital or other
- Study start
- 28 Jun 2011 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Other | Radiation: Stereotactic Radiosurgery (SRS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 )
Key exclusion criteria (15 listed)
- 3.2.1 Ineligible disease sites include the following
- Lymphoma
- Leukemia
- Multiple myeloma
- Primary CNS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Radiosurgery (SRS)Also: CyberKnife, Trilogy, True BeamDose 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 | Radiation | SBRT |
Primary outcome
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.
5 secondary outcomes
Serious Adverse Events related to treatment
Time frame: Up to 5 years
The Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: 5 years
Local control of metastatic sites
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Analysis of patterns of failure post-SRS/SBRT
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Burton, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiosurgery (SRS) in people with Recurrent Oligometastatic Disease, run by Steven Burton at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events Related to Treatment (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.