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

Primary Purpose

Kidney Cancer, Melanoma (Skin), Metastatic Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
questionnaire administration
3-dimensional conformal radiation therapy
hypofractionated radiation therapy
image-guided radiation therapy
tomotherapy
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring unspecified adult solid tumor, protocol specific, recurrent adult soft tissue sarcoma, recurrent melanoma, recurrent osteosarcoma, recurrent renal cell cancer, recurrent uterine sarcoma, stage IV adult soft tissue sarcoma, stage IV melanoma, stage IV uterine sarcoma, ovarian sarcoma, chondrosarcoma, metastatic osteosarcoma, stage IV renal cell cancer, lung metastases, liver metastases, bone metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation Therapy in Metastatic Cancer

Arm Description

Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Median Time to Local Progression
Interval from initiation of treatment on protocol to symptomatic or radiographic progression.
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.
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.
Pain at Sites of Metastases
Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.
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.

Full Information

First Posted
October 25, 2007
Last Updated
November 16, 2016
Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00550654
Brief Title
Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain
Official Title
A Phase II Study of Hypofractionated Highly Conformal Radiation With Helical Tomotherapy for Extra-Cranial Oligo
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to poor accrual.
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Melanoma (Skin), Metastatic Cancer, Ovarian Cancer, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific, recurrent adult soft tissue sarcoma, recurrent melanoma, recurrent osteosarcoma, recurrent renal cell cancer, recurrent uterine sarcoma, stage IV adult soft tissue sarcoma, stage IV melanoma, stage IV uterine sarcoma, ovarian sarcoma, chondrosarcoma, metastatic osteosarcoma, stage IV renal cell cancer, lung metastases, liver metastases, bone metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation Therapy in Metastatic Cancer
Arm Type
Experimental
Arm Description
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Other Intervention Name(s)
Brief Pain Inventory
Intervention Description
Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.
Intervention Type
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Intervention Description
Conformal radiation therapy improves the ability to spare normal tissues.
Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiation therapy
Intervention Description
Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.
Intervention Type
Radiation
Intervention Name(s)
image-guided radiation therapy
Intervention Description
Image guided radiation therapy targets the specific site of disease.
Intervention Type
Radiation
Intervention Name(s)
tomotherapy
Intervention 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.
Primary Outcome Measure Information:
Title
6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame
9 months, 11 days
Title
Median Time to Local Progression
Description
Interval from initiation of treatment on protocol to symptomatic or radiographic progression.
Time Frame
6-12 months
Title
12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment
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.
Time Frame
12 months
Title
Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis
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.
Time Frame
One to three months of followup
Title
Pain at Sites of Metastases
Description
Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.
Time Frame
One and three months of follow up
Title
Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy
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.
Time Frame
Baseline and prior to termination of systemic therapy or protocol withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah E. Citrin, MD
Organizational Affiliation
NCI - Radiation Oncology Branch; ROB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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