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NCT00550654 · REGISTRY CONDITION SEARCH

Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-01-13

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease

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outcome · POSTED

Number of Participants With Adverse Events

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outcome · POSTED

Median Time to Local Progression

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outcome · POSTED

12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment

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outcome · POSTED

Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis

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outcome · POSTED

Pain at Sites of Metastases

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outcome · POSTED

Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Pathologically confirmed cancer * No active disease at the primary site as assessed by physical examination, clinical evaluation, or site-specific imaging * 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: * No more than two metastases in the proximal bronchial tree area (defined as 2 cm from the trachea or mainstem bronchi) * Carbon monoxide diffusing capacity (DLCO) \> 30% predicted and forced expiratory volume 1 (FEV1) \> 1.2 L (in patients with more than one metastatic site in the lungs) * 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: * Proposed site(s) of treatment has been previously treated with radiotherapy * Metastatic site(s) requires emergent treatment (e.g., spinal cord compression, cauda equina, airway compromise, or life-threatening end-organ dysfunction) * Disease that is untreated or previously treated and progressive in the brain * Pathologic fracture or impending pathologic fracture at the metastatic site * Metastatic site(s) of a disease histology that is known to be sensitive to low doses of radiotherapy (e.g., pure seminoma, lymphoma, or small cell carcinoma) * 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: * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Life expectancy \> 12 weeks as assessed by the consulting radiation oncologist * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of lupus erythematosus or scleroderma * No known hypersensitivity to therapeutic radiotherapy * No other malignancy within the past 2 years except nonmelanoma skin cancer or in situ malignancies of the cervix, bladder, or head and neck * No unrelated systemic illness that, in the judgment of the investigator, would compromise the patient's ability to tolerate study therapy or would likely interfere with study procedures or results * Able or likely to adhere to study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 2 weeks since prior and no concurrent chemotherapy * Prior or concurrent hormonal agents, including antiandrogens, gonadotropin-releasing hormone agonists, aromatase inhibitors, tamoxifen, or similar agents allowed * No change in systemic therapy for 6 weeks before or within 4 weeks after initiating study radiotherapy
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
    intervention Names
    1. Other: questionnaire administration
    2. Radiation: 3-dimensional conformal radiation therapy
    3. Radiation: hypofractionated radiation therapy
    4. Radiation: image-guided radiation therapy
    5. Radiation: tomotherapy
    label
    Radiation Therapy in Metastatic Cancer
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Radiation Therapy in Metastatic Cancer
    description
    Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.
    name
    questionnaire administration
    other Names
    1. Brief Pain Inventory
    type
    OTHER
  2. arm Group Labels
    1. Radiation Therapy in Metastatic Cancer
    description
    Conformal radiation therapy improves the ability to spare normal tissues.
    name
    3-dimensional conformal radiation therapy
    type
    RADIATION
  3. arm Group Labels
    1. Radiation Therapy in Metastatic Cancer
    description
    Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.
    name
    hypofractionated radiation therapy
    type
    RADIATION
  4. arm Group Labels
    1. Radiation Therapy in Metastatic Cancer
    description
    Image guided radiation therapy targets the specific site of disease.
    name
    image-guided radiation therapy
    type
    RADIATION
  5. arm Group Labels
    1. Radiation Therapy in Metastatic Cancer
    description
    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.
    name
    tomotherapy
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease
    time Frame
    6 months
secondary Outcomes
  1. description
    Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
    measure
    Number of Participants With Adverse Events
    time Frame
    9 months, 11 days
  2. description
    Interval from initiation of treatment on protocol to symptomatic or radiographic progression.
    measure
    Median Time to Local Progression
    time Frame
    6-12 months
  3. description
    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.
    measure
    12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment
    time Frame
    12 months
  4. description
    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.
    measure
    Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis
    time Frame
    One to three months of followup
  5. description
    Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.
    measure
    Pain at Sites of Metastases
    time Frame
    One and three months of follow up
  6. description
    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.
    measure
    Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy
    time Frame
    Baseline and prior to termination of systemic therapy or protocol withdrawal
Full study description
brief Summary
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.
detailed Description
OBJECTIVES: Primary * To evaluate local control (defined as absence of local progression) at all treated sites of metastatic disease in patients with extracranial oligometastases treated with ablative doses of highly conformal radiotherapy delivered with helical tomotherapy. * To evaluate local control at each treated site of metastatic disease in these patients. Secondary * To determine median time to local progression in patients treated with this regimen. * To evaluate interfraction and intrafraction motion with megavoltage computed tomography (CT) imaging based on site of metastasis in these patients. * To compare tumor growth during systemic therapy in tumors treated with targeted radiotherapy vs newly developed tumors that have not been treated with radiotherapy. * To evaluate if treatment with hypofractionated highly conformal radiotherapy with helical tomotherapy can improve pain scores and decrease the need for analgesia in these patients. 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.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice