Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
1-Year Locoregional Progression-free survival (PFS) |
The proportion of previously-irradiated patients treated with SBRT, cetuximab, and/or docetaxel, evaluated by PET/CT per RECIST Criteria v1.1 that do not experience locoregional disease progression within one year. Per RECIST, Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). |
Up to 12 months |
|
| Primary |
Incidence of distant disease |
The proportion of patients with distant disease evaluated by PET/CT or CT per RECIST Criteria v1.1. Malignant disease that has spread to other organs or to lymph nodes other than those near the primary tumor. Per RECIST, Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). |
Up to 12 months |
|
| Primary |
Acute toxicities |
Adverse Events and Serious Adverse Events determined by patient follow up per CTCAE v4.0 criteria. |
Up to 3 months after SBRT treatment |
|
| Primary |
Late toxicities |
Adverse Events and Serious Adverse Events determined by patient follow up per CTCAE v4.0 criteria. |
From 3 months after SBRT treatment, up to 3 years |
|
| Secondary |
Objective Response Rate (ORR) |
Incidence of either a confirmed Complete Response (CR) or Partial Response (PR), per RECIST Criteria v1.1. Per RECIST, CR is defined as the disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met. |
Up to 12 months |
|
| Secondary |
Overall Survival (OS) |
Time from the date of randomization to the date of death due to any cause. |
Up to 5 years |
|
| Secondary |
University of Washington QOL Assessment Tool (UW-QOL) |
The UW-QOL is a patient-reported outcome measure consisting of domains based upon discrete ordinal responses regarding their past 7 days. Scoring is scaled to so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response. 12 single question domains, these having between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety. Another question asks patients to choose up to three of these domains that have been the most important to them. There are also three global questions, one about how patients feel relative to before they developed their cancer, one about their health-related QOL and one about their overall QOL. |
Up to 5 years |
|
| Secondary |
Progression-free Survival (PFS) |
Time from the date of entry on study to the date of progression per RECIST Criteria v1.1 or the date of death from any cause. Subjects who are alive and have not progressed will be censored at their last follow-up date. Per RECIST, Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). |
Up to 5 years |
|
