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

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ClinicalTrials.gov Identifier: NCT00550654
Recruitment Status : Terminated (Study was terminated due to poor accrual.)
First Posted : October 30, 2007
Results First Posted : September 18, 2012
Last Update Posted : January 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Deborah Citrin, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Kidney Cancer
Melanoma (Skin)
Metastatic Cancer
Ovarian Cancer
Sarcoma
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Other: questionnaire administration
Radiation: 3-dimensional conformal radiation therapy
Radiation: hypofractionated radiation therapy
Radiation: image-guided radiation therapy
Radiation: tomotherapy
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiation Therapy in Metastatic Cancer
Hide Arm/Group Description Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Radiation Therapy in Metastatic Cancer
Hide Arm/Group Description Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
1
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
71.6 [1]   (NA)
[1]
It wasn't possible to calculate a standard deviation since there was only one participant.
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
 100.0%
1.Primary Outcome
Title 6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No data/specimens were collected. Study was terminated due to poor accrual.
Arm/Group Title Radiation Therapy in Metastatic Cancer
Hide Arm/Group Description:
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation Therapy in Metastatic Cancer
Hide Arm/Group Description:
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Participants
1
3.Secondary Outcome
Title Median Time to Local Progression
Hide Description Interval from initiation of treatment on protocol to symptomatic or radiographic progression.
Time Frame 6-12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data/specimens were collected. Study was terminated due to poor accrual.
Arm/Group Title Radiation Therapy in Metastatic Cancer
Hide Arm/Group Description:
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title 12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No data/specimens were collected. Study was terminated due to poor accrual.
Arm/Group Title Radiation Therapy in Metastatic Cancer
Hide Arm/Group Description:
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No data/specimens were collected. Study was terminated due to poor accrual.
Arm/Group Title Radiation Therapy in Metastatic Cancer
Hide Arm/Group Description:
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Pain at Sites of Metastases
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No data/specimens were collected. Study was terminated due to poor accrual.
Arm/Group Title Radiation Therapy in Metastatic Cancer
Hide Arm/Group Description:
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
No data/specimens were collected. Study was terminated due to poor accrual.
Arm/Group Title Radiation Therapy in Metastatic Cancer
Hide Arm/Group Description:
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radiation Therapy in Metastatic Cancer
Hide Arm/Group Description Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
All-Cause Mortality
Radiation Therapy in Metastatic Cancer
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Radiation Therapy in Metastatic Cancer
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radiation Therapy in Metastatic Cancer
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Gastrointestinal disorders   
Diarrhea  1  1/1 (100.00%)  1
Anorexia  1  1/1 (100.00%)  1
Taste alteration (dysgeusia)  1  1/1 (100.00%)  1
Nausea  1  1/1 (100.00%)  1
General disorders   
Weight loss  1  1/1 (100.00%)  1
Fatigue (asthenia, lethargy, malaise)  1  1/1 (100.00%)  1
Musculoskeletal and connective tissue disorders   
Pain::Buttock  1  1/1 (100.00%)  1
Pain::Extremity-limb  1  1/1 (100.00%)  1
Renal and urinary disorders   
Urinary retention (including neurogenic bladder)  1  1/1 (100.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonitis/pulmonary infiltrates  1  1/1 (100.00%)  1
Hemorrhage, pulmonary/upper respiratory: Nose  1  1/1 (100.00%)  1
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other (Specify)  1  1/1 (100.00%)  1
Rash/desquamation  1  1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv2.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Deborah Citrin, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-5457
Responsible Party: Deborah Citrin, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00550654     History of Changes
Other Study ID Numbers: 070230
NCI-07-C-0230
First Submitted: October 25, 2007
First Posted: October 30, 2007
Results First Submitted: August 20, 2012
Results First Posted: September 18, 2012
Last Update Posted: January 13, 2017