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Participant enrollment was negatively impacted by medical oncology treatment with systemic therapy alone and accrual to other clinical trials.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiosurgery (SRS) | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptable Toxicity of SRS/SBRT | Number of distinct patients with toxicities of Grade 3 or less per CTCAE v4.0 | Up to 3 Years (per patient) |
| Presence of Multiple Metastatic Sites | The presence of multiple metastatic disease sites (between 2 and 5 sites). | Up to 3 years (per patient) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
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:
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
Severe, active co-morbidity, defined as follows:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Steve J Burton, MD | UPMC Hillman Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center - Radiation Oncology | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy | 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. 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. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met. Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy | 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. 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. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met. Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptable Toxicity of SRS/SBRT | Number of distinct patients with toxicities of Grade 3 or less per CTCAE v4.0 | All treated patients able to be evaluated for toxicity grading. | Posted | Number | participants | Up to 3 Years (per patient) |
|
Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy | 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. 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. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met. Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | NCI CTCAE v4 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | NCI CTCAE v4 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara M. Stadterman, MPH, MSCR | UPMC Hillman Cancer Center | 412-647-5554 | stadtermanbm@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2023 | Jun 29, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C536678 | Snyder Robinson syndrome |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
|
| Chemotherapy | Drug | Chemotherapy choice of agents is at the discretion of the treating medical oncologist. |
|
| 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. | 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. | 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. | 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. | Up to 5 years (per patient) |
| Two-year Overall Survival | Percentage of participants alive at 2 years post start of treatment. | 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. | Up to 5 years (cohort) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Presence of Multiple Metastatic Sites | The presence of multiple metastatic disease sites (between 2 and 5 sites). | No data collected in the analysis population. | Posted | Up to 3 years (per patient) |
|
|
| Secondary | 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. | Participants that completed both pre and post treatment patient outcomes assessments. | Posted | Mean | Standard Deviation | score on a scale | At pre-treatment |
|
|
|
| Secondary | 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. | Participants that completed both pre and post treatment patient outcomes assessments. | Posted | Mean | Standard Deviation | score on a scale | At post-treatment |
|
|
|
| Secondary | 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. | No data collected in the analysis population | Posted | Up to 5 years (per patient) |
|
|
| Secondary | 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. | No data collected in the analysis population. | Posted | Up to 5 years |
|
|
| Secondary | 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. | Patients that received study treatment and were radiologically evaluated for confirmed disease progression. | Posted | Count of Participants | Participants | Up to 5 years (per patient) |
|
|
|
| Secondary | Two-year Overall Survival | Percentage of participants alive at 2 years post start of treatment. | Participants that received study treatment. | Posted | Number | percentage of participants | At 2 years (cohort) |
|
|
|
| Secondary | 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. | Participants that received study treatment. | Posted | Mean | Standard Error | months | Up to 5 years (cohort) |
|
|
|
| 15 |
| 24 |
| 1 |
| 24 |
| 2 |
| 24 |
| Coronary artery disease | Cardiac disorders | NCI CTCAE v4 | Systematic Assessment |
|
| Fatigue | General disorders | NCI CTCAE v4 | Systematic Assessment |
|
| Diabetes | General disorders | NCI CTCAE v4 | Systematic Assessment |
|
| Hyperlipidemia | Investigations | NCI CTCAE v4 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | NCI CTCAE v4 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Systematic Assessment |
|
| Depression | Psychiatric disorders | NCI CTCAE v4 | Systematic Assessment |
|
| Hypertension | Vascular disorders | NCI CTCAE v4 | Systematic Assessment |
|
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| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Title | Measurements |
|---|---|
|
| Functional Well-being |
|
| Total Well-being |
|
| Title | Measurements |
|---|---|
|
| Functional Well-being |
|
| Total Well-being |
|