Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor
NCT ID: NCT03599765
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
380 participants
INTERVENTIONAL
2018-07-31
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. In patients with oligometastatic malignancies, to assess PFS with upfront LCT vs. no LCT among randomized patients. In this analysis each disease site will be analyzed separately.
SECONDARY OBJECTIVES:
I. In patients with oligometastatic malignancies, to assess OS with upfront LCT vs. no LCT among randomized patients. In this analysis disease sites will be amalgamated and analysis will compare randomized arms.
II. In patients with oligometastatic malignancies, to assess time to next line systemic therapy with upfront LCT vs. no LCT. The subsequent line of systemic therapy will be defined as the subsequent line after protocol specified systemic therapy.
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. Separate analyses will assess 1) all disease sites amalgamated and 2) all disease sites analyzed separately.
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 castrateresistance 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.
ARM II: Patients receive routine drug therapy. Patients may later receive LCT at the discretion of doctor.
After completion of study, patients are followed up every 18 weeks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I (LCT, routine therapy)
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.
Best Practice
Receive routine therapy
Local Consolidation Therapy
Receive LCT
Arm II (routine therapy)
Patients receive routine drug therapy. Patients may later receive LCT at the discretion of doctor.
Best Practice
Receive routine therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Best Practice
Receive routine therapy
Local Consolidation Therapy
Receive LCT
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chad Tang
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ludmir EB, Sherry AD, Fellman BM, Liu S, Bathala T, Haymaker C, Medina-Rosales MN, Reuben A, Holliday EB, Smith GL, Noticewala SS, Nicholas S, Price TR, Martin-Paulpeter RM, Perles LA, Lee SS, Lee MS, Smaglo BG, Huey RW, Willis J, Zhao D, Cohen L, Taniguchi CM, Koay EJ, Katz MHG, Wolff RA, Das P, Pant S, Koong AC, Tang C. Addition of Metastasis-Directed Therapy to Systemic Therapy for Oligometastatic Pancreatic Ductal Adenocarcinoma (EXTEND): A Multicenter, Randomized Phase II Trial. J Clin Oncol. 2024 Nov 10;42(32):3795-3805. doi: 10.1200/JCO.24.00081. Epub 2024 Aug 5.
Tang C, Sherry AD, Haymaker C, Bathala T, Liu S, Fellman B, Cohen L, Aparicio A, Zurita AJ, Reuben A, Marmonti E, Chun SG, Reddy JP, Ghia A, McGuire S, Efstathiou E, Wang J, Wang J, Pilie P, Kovitz C, Du W, Simiele SJ, Kumar R, Borghero Y, Shi Z, Chapin B, Gomez D, Wistuba I, Corn PG. Addition of Metastasis-Directed Therapy to Intermittent Hormone Therapy for Oligometastatic Prostate Cancer: The EXTEND Phase 2 Randomized Clinical Trial. JAMA Oncol. 2023 Jun 1;9(6):825-834. doi: 10.1001/jamaoncol.2023.0161.
Related Links
Access external resources that provide additional context or updates about the study.
MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2018-01469
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0349
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0349
Identifier Type: -
Identifier Source: org_study_id