Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria: - Oligometastatic solid tumors (see protocol for relevant disease sites) patients (=< 5 metastatic lesions at the time of study entry) - Candidate for definitive local therapy to all sites of active disease per the discretion of the treating physicians - No more than 4 prior lines of systemic therapy administered to treat metastatic disease - Pathologically confirmed diagnosis of cancer as specified in protocol - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Absolute neutrophil count (ANC) >= 500/mcL (performed within 6 weeks prior to study enrollment) - Platelets >= 25,000/mcL (performed within 6 weeks prior to study enrollment) - Hemoglobin >=7 g/dL (performed within 6 weeks prior to study 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) - 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: - Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy - 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 - 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 - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial - In the event that a curative systemic option exists for metastatic disease from a given disease site. First-line metastatic patients (those patients who have had no prior lines of systemic therapy targeting their metastatic disease) are only eligible for enrollment if they have completed their curative systemic therapy per the judgment of the treating oncologist and have persistent disease - 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 - 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)

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events;Progression free survival;Time to development of new distant metastases;Overall survival

Secondary Outcome Measures

Name	Time	Method

Related Trials

A protocol of 3-D conformal external beam radiotherapy planning for lung cancer with functional lung

Not Applicable

Department of radiation oncology, Hiroshima University

Updated 10/17/2023

Feasibility study of external beam radiation therapy followed by high-dose rate endorectal brachytherapy (HDRBT) in inoperable rectal cancer patients

Phase 2

Antoni van Leeuwenhoek Ziekenhuis

Updated 5/13/2024

Reduction of radiation exposure and contrast material volume in coronary CT angiography with low tube voltage and iterative reconstruction technique

Not Applicable

Keio University

Updated 10/17/2023