Recurrent Oligometastatic Disease Clinical Trial
Official title:
Phase II Study of Stereotactic Radiosurgery for Patients With Oligo-recurrent Disease
| Verified date | May 2023 |
| Source | University of Pittsburgh |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the feasibility of radiosurgery for all metastatic sites in patients presenting with oligometastatic disease, defined here as 5 or fewer sites of metastatic disease involving 3 or fewer organ systems.
| Status | Completed |
| Enrollment | 173 |
| Est. completion date | October 11, 2022 |
| Est. primary completion date | October 13, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 3.1 Conditions for Patient Eligibility 3.1.1 Pathologically (histologically or cytologically) proven diagnosis of solid malignancy 3.1.2 Eligible disease sites include the following - Breast - Prostate - GI (including colorectal, anal, esophagus, pancreas, gastric with the exception of patients with colon cancer and liver-only metastatic disease ) - Head and neck - Skin (melanoma and squamous cell carcinoma) - Lung (both small cell and non-small cell) - Sarcoma (both soft tissue and bone) - Gynecologic (endometrial, cervical, ovarian, vaginal, vulvar) 3.1.3 Patients are stage IV (M1) or recurrent with any combination of T and N with oligometastatic disease as defined by 5 or fewer total sites of metastatic disease 3.1.4 Can have recurrent disease from the primary disease (this is definition of oligorecurrent disease) but cannot have any other primary cancer diagnosed or treated within the last 3 years other than cutaneous skin cancer. 3.1.5 Prior systemic chemotherapy is allowable 3.1.4 Zubrod Performance Status 0-1 3.1.5 Age = 18 3.1.6 CBC/differential obtained within 4 weeks prior to registration on study, with adequate bone marrow function defined as follows: 3.1.6.1 Absolute neutrophil count (ANC) = 1,800 cells/mm3; 3.1.6.2 Platelets = 100,000 cells/mm3; 3.1.6.3 Hemoglobin = 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb = 8.0 g/dl is acceptable.); 3.1.7 Women of childbearing potential and male participants must practice adequate contraception 3.1.8 Patient must provide study specific informed consent prior to study entry Exclusion Criteria: 3.2.1 Ineligible disease sites include the following - Lymphoma - Leukemia - Multiple myeloma - Primary CNS - Peritoneal carcinomatosis - Colon cancer with liver-only metastatic disease that is treatable with surgical resection 3.2.2 Other - Diffuse metastatic spread confined to one organ system is ineligible; examples of this include leptomeningeal spread in the CNS and peritoneal carcinomatosis. - Metastatic disease sites must be treatable with stereotactic radiosurgery (at discretion of treating physician). Patients with oligometastatic sites not amenable to SRS treatment, either through size or locations, are ineligible for this trial. 3.2.4 Severe, active co-morbidity, defined as follows: 3.2.4.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; 3.2.4.2 Transmural myocardial infarction within the last 6 months; 3.2.4.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; 3.2.4.4 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. 3.2.5 Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. 3.2.6 Patients unable to have an FDG-PET scan, either through insurance coverage, patient decision or other reason are not eligible for this study. 3.2.7 Oligometastatic disease sites not eligible based on concern for toxicity: - trachea involvement (direct invasion, tumors close to or abutting trachea are eligible) - heart (direct invasion or involvement, pericardial lymph nodes can be treated) 3.2.8 Patients unable to have SRS through insurance coverage or ability to pay for SRS |
| Country | Name | City | State |
|---|---|---|---|
| United States | UPMC Hillman Cancer Center - Radiation Oncology | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Steven Burton |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse Events Related to Treatment | Adverse Events as measured by CTCAE version 4.0, possibly, probably or definitely related to study treatment. | Up to 5 years | |
| Secondary | Serious Adverse Events related to treatment | Serious Adverse Events as measured by CTCAE version 4.0, possibly, probably or definitely related to study treatment. | Up to 5 years | |
| Secondary | The Functional Assessment of Cancer Therapy - General (FACT-G) | 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. | 5 years | |
| Secondary | Local control of metastatic sites | 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. | Up to 5 years | |
| Secondary | Overall survival (OS) | The (median) length of time from enrollment to confirmed death from any cause. | Up to 5 years | |
| Secondary | Analysis of patterns of failure post-SRS/SBRT | 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). | Up to 5 years |