Systemic Therapy with or without Local Consolidative Therapy in Treating Patients with Oligometastatic Solid Tumor
This phase II trial studies how well systemic therapy with or without local consolidative therapy works in treating patients with solid tumor that has spread to 1 or 2 other places in the body (oligometastatic). Treatment with up-front local consolidative therapy may be better in helping to control the disease.
Inclusion Criteria
- PRIOR TO CLINICAL ONCOLOGY RESEARCH (CORe) ENROLLMENT: No more than 4 prior lines of systemic therapy administered to treat metastatic disease
- PRIOR TO CLINICAL ONCOLOGY RESEARCH (CORe) ENROLLMENT: Be >= 18 years of age on the day of signing informed consent
- PRIOR TO CLINICAL ONCOLOGY RESEARCH (CORe) ENROLLMENT: Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- PRIOR TO CLINICAL ONCOLOGY RESEARCH (CORe) ENROLLMENT: Pathologically confirmed diagnosis of cancer
- FOLLOWING CORe ENROLLMENT: Oligometastatic solid tumors patients (=< 5 metastatic lesions at the time of study entry)
- FOLLOWING CORe ENROLLMENT: Candidate for definitive local therapy to all sites of active disease per the discretion of the treating physicians
- FOLLOWING CORe ENROLLMENT: Absolute neutrophil count (ANC) >= 500/mcL (performed within 6 weeks prior to study enrollment)
- FOLLOWING CORe ENROLLMENT: Platelets >= 25,000/mcL (performed within 6 weeks prior to study enrollment)
- FOLLOWING CORe ENROLLMENT: Hemoglobin >= 7 g/dL (performed within 6 weeks prior to study enrollment)
- FOLLOWING CORe ENROLLMENT: Serum total bilirubin =< 1.5 mg/dl (except for subjects with Gilbert syndrome, who may have total bilirubin < 3.0 mg/dl) OR direct bilirubin =< upper limit normal (ULN) for subjects with total bilirubin levels > 1.5 mg/dl (performed within 6 weeks prior to study enrollment)
- FOLLOWING CORe ENROLLMENT: Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) =< 3 X ULN OR =< 5 X ULN for subjects with liver metastases (performed within 6 weeks prior to study enrollment)
Exclusion Criteria
- PRIOR TO CORe ENROLLMENT: Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy
- PRIOR TO CORe ENROLLMENT: Is cognitively-impaired or has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- PRIOR TO CORe ENROLLMENT: Additional diagnosis of another primary malignancy outside of the malignancy being treated on trial that per the discretion of the treating physicians and investigational team offers a substantial risk to the patient’s life (e.g. primary lung cancer definitively treated in the past 6 months would offer a significant risk to the patient’s life, while a basal cell carcinoma treated with local excision would not)
- FOLLOWING CORe ENROLLMENT: Metastatic effusion (e.g. pleural effusion or ascites). Note that patients with an effusion that is too small to sample will be eligible for the trial
- FOLLOWING CORe ENROLLMENT: Diffuse metastatic processes including leptomeningeal disease, diffuse bone marrow involvement, and peritoneal carcinomatous, which by the discretion of the treating physician cannot be treated definitively
- FOLLOWING CORe ENROLLMENT: Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit * Female subject of childbearing potential should have a negative urine or serum pregnancy within 6 weeks prior to study registration up to the first fraction of radiation * Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03599765.
PRIMARY OBJECTIVE:
I. In patients with oligometastatic malignancies, to assess progression free survival (PFS) with upfront local consolidative therapy (LCT) versus (vs.) no LCT among randomized patients.
SECONDARY OBJECTIVES:
I. In patients with oligometastatic malignancies, to assess overall survival (OS) with upfront LCT vs. no LCT among randomized patients.
II. In patients with oligometastatic malignancies, to assess time to next line systemic therapy with upfront LCT vs. no LCT.
III. In patients with oligometastatic malignancies, to assess time to new lesion failure with upfront LCT vs. no LCT.
IV. To assess safety/tolerability of upfront LCT in patients with oligometastatic malignancies.
V. In patients with oligometastatic malignancies, to assess quality of life with upfront LCT vs. no LCT.
VI. In patients with oligometastatic malignancies, assess time to local failure with upfront LCT vs. no LCT.
VII. In patients with oligometastatic prostate cancer, assess radiographic progression-free survival with upfront LCT vs. no LCT.
VIII. In patients with oligometastatic castrate-sensitive prostate cancer, assess castrate-resistance free survival with upfront LCT vs. no LCT.
EXPLORATORY OBJECTIVES:
I. To identify predictive/prognostic biomarkers that are associated with a benefit to LCT across disease sites.
II. To investigate alterations in biomarker profile over time and in response to radiation delivery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive up-front standard of care LCT including but not limited to surgical resection, cryotherapy, and radiofrequency ablation. Patients then receive routine drug therapy. Additionally, patients undergo blood sample collection, biopsy of tumor, computed tomography (CT) scan, positron emission tomography (PET)/ CT scan and/or magnetic resonance imaging (MRI) throughout study.
ARM II: Patients receive routine drug therapy. Patients may later receive LCT at the discretion of doctor. Additionally, patients undergo blood sample collection, biopsy of tumor, CT scan, PET/ CT scan and/or MRI throughout study.
After completion of study, patients are followed up every 18 weeks.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorChad Tang
- Primary ID2018-0349
- Secondary IDsNCI-2018-01469
- ClinicalTrials.gov IDNCT03599765