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

Running, not enrolling · Phase 2

Conditions studied: Oligometastatic Malignant Solid Neoplasm

In brief

This phase II trial studies how well systemic therapy with or without local consolidative therapy work in treating patients with solid tumor that has spread to 1 site of other places in the body. Treatment with up-front local consolidative therapy may be better in helping to control the disease.

Key facts

Study ID

NCT03599765

Run by

M.D. Anderson Cancer Center

People needed

380

Starts

2018-07-31

Expected to finish

2029-12-31

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Baptist Health Medical Center — Little Rock, Arkansas, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• Community Health Center — Coldwater, Michigan, United States
• Cooper Hospital University Medical Center — Camden, New Jersey, United States
• OhioHealth Mansfield Hospital — Mansfield, Ohio, United States
• M D Anderson Cancer Center — Houston, Texas, United States
• MD Anderson in Katy — Houston, Texas, United States
• MD Anderson League City — Nassau Bay, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• MD Anderson in Sugar Land — Sugar Land, Texas, United States
• MD Anderson in The Woodlands — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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