Radiosurgery for Patients Recurrent Oligometastatic Disease
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|ClinicalTrials.gov Identifier: NCT01345552|
Recruitment Status : Active, not recruiting
First Posted : May 2, 2011
Last Update Posted : April 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Oligometastatic Disease||Radiation: Stereotactic Radiosurgery (SRS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||174 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Stereotactic Radiosurgery for Patients With Oligo-recurrent Disease (UPCI# 10-028)|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||February 2024|
Radiation: Stereotactic Radiosurgery (SRS)
Dose and fractionation will be dependent on the lesion location and lesion size and is up to 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. Note that patients can have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met. For example, if two lung lesions, brain, adrenal, and liver sites were being treated both lung sites could be treated Monday, Wednesday, and Friday and the adrenal, liver and brain lesions treated Tuesday, Thursday
- Detection of Benefit [ Time Frame: Up to 3 years ]Proportion of patients with oligometastatic disease that are able to complete stereotactic radiation (SRS).
- Adverse Events Related to Treatment [ Time Frame: Up to 5 years ]Adverse Events as measured by CTCAE version 4.0, possibly, probably or definitely related to study treatment.
- The Functional Assessment of Cancer Therapy - General (FACT-G) [ Time Frame: 5 years ]A a self-administered, 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Scaling of items: Five-point scale from 0 (not at all) to 4 (very much). Scoring: Subscale scores added to obtain total score. Alternative scoring includes the Trial Outcome Index (TOI), which is the sum of the Physical, Functional, Cancer Subscales. The TOI is reported to be an efficient and precise summary index of physical and functional outcomes. Higher scores indicated better quality of life.
- Local disease control [ Time Frame: Up to 5 years ]Proportion of patients with local control is defined as stable disease (SD), partial response (PR), or complete response (CR) in the target lesion, per RECIST v1.1. Complete Response (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 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.
- Overall survival (OS) [ Time Frame: Up to 5 years ]The (median) length of time from enrollment to confirmed death from any cause.
- Local failure [ Time Frame: Up to 5 years ]Proportion of patients with local failure (progressive disease (PD) within the target lesion. Per RECIST v1.1: Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345552
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Steve Burton, MD||University of Pittsburgh|