Oligometastatic DiseasePhase 2NCT01345539
Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation
A Phase 2 study testing Stereotactic Radiosurgery (SRS) and Chemotherapy in people with 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
- Oligometastatic Disease
- What is being tested?
- Stereotactic Radiosurgery (SRS) and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2013to 20 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pathologically (histologically or cytologically) proven diagnosis of solid malignancy within 8 weeks of registration
- 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
Show all 19Show fewer
- 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) 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.
Who cannot join
- Ineligible disease sites include the following
- Lymphoma
- Leukemia
- Multiple myeloma
- Primary CNS
- Peritoneal carcinomatosis
Show all 28Show fewer
- Colon cancer with resectable liver-only lesions
- 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)
- 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.
- 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.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- 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.
- 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.
- 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)
- Patients unable to have an FDG-PET/CT scan, either through insurance coverage, patient decision or other reason are not eligible for this study.
- 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 for Curative Intent Treatment for Patients With Oligometastatic Disease at Initial Presentation
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
- Oligometastatic Disease
- Being tested
- Stereotactic Radiosurgery (SRS), Chemotherapy
- Keywords
- Oligo mets, Radiosurgery, 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, 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. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
ChemotherapyDrug
Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) with/without chemotherapy | Experimental | Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.
Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed. Receives: Radiation: Stereotactic Radiosurgery (SRS); Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptable Toxicity of SRS/SBRT
Number of distinct patients with toxicities of Grade 3 or less per CTCAE v4.0
Measured: Up to 3 Years (per patient)
Presence of Multiple Metastatic Sites
The presence of multiple metastatic disease sites (between 2 and 5 sites).
Measured: Up to 3 years (per patient)
Secondary outcomes (7)
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life Score
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of life Assessment is a patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical (PW), social (SW), emotional (EW), and functional (FW) well-being. Scoring: Five-point scale for each of the subscales is: 0 (not at all) to 4 (very much). PW has a Score range from 0-28. SW has a Score range from 0-28. EW has a Score range from 0-24. FW has a Score range from 0-28. Total overall score is thus from minimum of 0 to maximum of 108. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.
Measured: At pre-treatment
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Score
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of life Assessment is a patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical (PW), social (SW), emotional (EW), and functional (FW) well-being. Scoring: Five-point scale for each of the subscales is: 0 (not at all) to 4 (very much). PW has a Score range from 0-28. SW has a Score range from 0-28. EW has a Score range from 0-24. FW has a Score range from 0-28. Total overall score is thus from minimum of 0 to maximum of 108. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.
Measured: At post-treatment
Local Control of Metastatic Disease
Proportion of patients with local Complete Response (CR), Partial Response (PR) or Stable Disease (SD) after trial therapy as measured according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at sites of metastatic disease. Per RECIST: (CR): Disappearance of all target lesions; (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (SD) 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 (per patient)
Local Control of Primary Disease
Proportion of patients with local Complete Response (CR), Partial Response (PR) or Stable Disease (SD) after trial therapy as measured according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at primary disease sites. Per RECIST: (CR): Disappearance of all target lesions; (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (SD) 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
Analysis of Patterns of Failure Post-SRS/SBRT
The number of patients that experience oligometastatic disease progression/recurrence after treatment for their primary disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at primary disease sites. Per RECIST, Progressive Disease (PD) includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: Up to 5 years (per patient)
Two-year Overall Survival
Percentage of participants alive at 2 years post start of treatment.
Measured: At 2 years (cohort)
Overall Survival (OS)
Mean number of months patients remain alive from the day of trial enrollment until either an death from any cause or last follow-up.
Measured: Up to 5 years (cohort)
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 start7 Jun 2013
- Primary completion3 May 2022
- Study completion20 Oct 2022
Why it stopped: Participant enrollment was negatively impacted by medical oncology treatment with systemic therapy alone and accrual to other clinical trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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 J Burton, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345539
- Sponsor's protocol ID
- HCC 10-027
- Status last verified
- Sep 2023
- First submitted
- 17 Feb 2011
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study for Curative Intent Treatment for Patients With Oligometastatic Disease at Initial Presentation
- ClinicalTrials.gov ID
- NCT01345539
- Acronym / sponsor ID
- HCC 10-027
- Conditions
- Oligometastatic Disease
- Keywords
- Oligo mets, Radiosurgery, Stereotactic Body Radiotherapy (SBRT) (Stereotactic radiosurgery (SRS) plus stereotactic radiotherapy (SRT))
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant enrollment was negatively impacted by medical oncology treatment with systemic therapy alone and accrual to other clinical trials.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Steven BurtonUniversity, hospital or other
- Study start
- 7 Jun 2013 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 2 May 2011 (estimated)
- Results
- Posted 11 Oct 2023
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 |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) with/without chemotherapy | Experimental | Radiation: Stereotactic Radiosurgery (SRS), Drug: ChemotherapySequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease. Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Pathologically (histologically or cytologically) proven diagnosis of solid malignancy within 8 weeks of registration
- Eligible disease sites include the following
- 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.
Key exclusion criteria (28 listed)
- Ineligible disease sites include the following
- Examples of patients ineligible for trial
- Other
- 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.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
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, 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. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met. | Radiation | Stereotactic Body Radiotherapy (SBRT) with/without chemotherapy |
| ChemotherapyChemotherapy choice of agents is at the discretion of the treating medical oncologist. | Drug | Stereotactic Body Radiotherapy (SBRT) with/without chemotherapy |
Primary outcome
Acceptable Toxicity of SRS/SBRT
Time frame: Up to 3 Years (per patient)
Number of distinct patients with toxicities of Grade 3 or less per CTCAE v4.0
Presence of Multiple Metastatic Sites
Time frame: Up to 3 years (per patient)
The presence of multiple metastatic disease sites (between 2 and 5 sites).
7 secondary outcomes
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life Score
Time frame: At pre-treatment
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Score
Time frame: At post-treatment
Local Control of Metastatic Disease
Time frame: Up to 5 years (per patient)
Local Control of Primary Disease
Time frame: Up to 5 years
Analysis of Patterns of Failure Post-SRS/SBRT
Time frame: Up to 5 years (per patient)
Two-year Overall Survival
Time frame: At 2 years (cohort)
Overall Survival (OS)
Time frame: Up to 5 years (cohort)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 J Burton, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Radiosurgery (SRS) and Chemotherapy in people with 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 19 inclusion and 28 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: stopped early, as of the sponsor's last update on 11 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptable Toxicity of SRS/SBRT (time frame: Up to 3 Years (per patient)). The study lists 2 primary outcomes in all. 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 11 Oct 2023.