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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-07-C-0230 |
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Study was terminated due to poor accrual.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well conformal radiation therapy works in treating patients with metastatic cancer outside the brain.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to histology (renal cell carcinoma vs melanoma vs sarcoma vs other histologies).
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions. Patients undergo megavoltage imaging before and after each fraction to verify the positioning of each target lesion.
Patients complete a pain assessment questionnaire at baseline and at 1 and 3 months after treatment.
After completion of study therapy, patients are followed at 1 and 3 months and then every 3 months for up to 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy in Metastatic Cancer | Experimental | Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease | Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. | 9 months, 11 days |
| Median Time to Local Progression |
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DISEASE CHARACTERISTICS:
Pathologically confirmed cancer
Measurable metastatic disease meeting the following criteria:
Four or fewer sites of extracranial lesions < 5 cm in size
If metastatic site(s) is within the lung, the following criteria must be met:
If metastatic site(s) is within 2 cm of either kidney, creatinine level must be < 1.5 times upper limit of normal (ULN)
If metastatic site(s) is within 2 cm of the liver, bilirubin level must be < 1.5 times ULN
Patients with metastatic disease that meets any of the following criteria are excluded:
Patients in whom surgery is deemed an appropriate option as standard of care (e.g., isolated lung metastasis from sarcoma or isolated liver metastasis from colon cancer) but who refuse surgical therapy are eligible
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah E. Citrin, MD | NCI - Radiation Oncology Branch; ROB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland | 20892-1182 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy in Metastatic Cancer | Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 3-dimensional conformal radiation therapy | Radiation | Conformal radiation therapy improves the ability to spare normal tissues. |
|
| hypofractionated radiation therapy | Radiation | Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short. |
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| image-guided radiation therapy | Radiation | Image guided radiation therapy targets the specific site of disease. |
|
| tomotherapy | Radiation | Tomotherapy is a delivery method which provides megavoltage computed tomography (CT) localization and may provide superior conformality and localization compared to other dynamic intensity modulated radiation therapy techniques. |
|
Interval from initiation of treatment on protocol to symptomatic or radiographic progression.
| 6-12 months |
| 12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment | Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression. Progression is an interval increase in the maximal dimension of the target lesion. | 12 months |
| Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis | Megavoltage localization scans will be obtained and the physician and therapist will evaluate the cone beam image and compare this image to the expected image based on the patient's initial planning CT scan. | One to three months of followup |
| Pain at Sites of Metastases | Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria. | One and three months of follow up |
| Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy | Rate of growth of the composite (total) treated volume (up to four sites) compared to the composite volume of up to four newly identified and untreated prospectively-identified (at the time of systemic progression) metastatic sites. Volume doubling time will be calculated assuming an exponential growth pattern. | Baseline and prior to termination of systemic therapy or protocol withdrawal |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy in Metastatic Cancer | Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | 6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease | Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion. | No data/specimens were collected. Study was terminated due to poor accrual. | Posted | 6 months |
|
| |||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. | Posted | Number | Participants | 9 months, 11 days |
|
| ||||||||||||||||||
| Secondary | Median Time to Local Progression | Interval from initiation of treatment on protocol to symptomatic or radiographic progression. | No data/specimens were collected. Study was terminated due to poor accrual. | Posted | 6-12 months |
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| |||||||||||||||||||
| Secondary | 12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment | Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression. Progression is an interval increase in the maximal dimension of the target lesion. | No data/specimens were collected. Study was terminated due to poor accrual. | Posted | 12 months |
|
| |||||||||||||||||||
| Secondary | Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis | Megavoltage localization scans will be obtained and the physician and therapist will evaluate the cone beam image and compare this image to the expected image based on the patient's initial planning CT scan. | No data/specimens were collected. Study was terminated due to poor accrual. | Posted | One to three months of followup |
|
| |||||||||||||||||||
| Secondary | Pain at Sites of Metastases | Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria. | No data/specimens were collected. Study was terminated due to poor accrual. | Posted | One and three months of follow up |
|
| |||||||||||||||||||
| Secondary | Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy | Rate of growth of the composite (total) treated volume (up to four sites) compared to the composite volume of up to four newly identified and untreated prospectively-identified (at the time of systemic progression) metastatic sites. Volume doubling time will be calculated assuming an exponential growth pattern. | No data/specimens were collected. Study was terminated due to poor accrual. | Posted | Baseline and prior to termination of systemic therapy or protocol withdrawal |
|
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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 | Radiation Therapy in Metastatic Cancer | Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions. | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain::Buttock | Musculoskeletal and connective tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTCv2.0 | Systematic Assessment |
| |
| Weight loss | General disorders | CTCv2.0 | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify) | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
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| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCv2.0 | Systematic Assessment |
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| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
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| Pain::Extremity-limb | Musculoskeletal and connective tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory: Nose | Respiratory, thoracic and mediastinal disorders | CTCv2.0 | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCv2.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCv2.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Citrin, M.D. | National Cancer Institute, National Institutes of Health | 301-496-5457 | citrind@mail.nih.gov |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D008545 | Melanoma |
| D009362 | Neoplasm Metastasis |
| D010051 | Ovarian Neoplasms |
| D012509 | Sarcoma |
| D012516 | Osteosarcoma |
| D002292 | Carcinoma, Renal Cell |
| D002813 | Chondrosarcoma |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D061089 | Radiotherapy, Image-Guided |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories |
|---|
|