NCT03599765

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for phase_2

Timeline
44mo left

Started Jul 2018

Longer than P75 for phase_2

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jul 2018Dec 2029

First Submitted

Initial submission to the registry

July 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

11.4 years

First QC Date

July 17, 2018

Last Update Submit

December 29, 2025

Conditions

Oligometastatic Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (4)

  • Incidence of adverse events

    General descriptive statistics will be computed.

    Up to 1 year

  • Progression free survival

    Up to 1 year

  • Time to development of new distant metastases

    Up to 1 year

  • Overall survival

    Up to 1 year

Study Arms (2)

Arm I (LCT, routine therapy)

EXPERIMENTAL

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.

Other: Best PracticeProcedure: Local Consolidation Therapy

Arm II (routine therapy)

EXPERIMENTAL

Patients receive routine drug therapy. Patients may later receive LCT at the discretion of doctor.

Other: Best Practice

Interventions

Best PracticeOTHER

Receive routine therapy

Also known as: standard of care, standard therapy
Arm I (LCT, routine therapy)Arm II (routine therapy)
Local Consolidation TherapyPROCEDURE

Receive LCT

Also known as: LCT, Local Consolidative Therapy
Arm I (LCT, routine therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Community Health Center

Coldwater, Michigan, 49036, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

OhioHealth Mansfield Hospital

Mansfield, Ohio, 44903, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson in Katy

Houston, Texas, 77094, United States

Location

MD Anderson League City

Nassau Bay, Texas, 77058, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

Location

MD Anderson in The Woodlands

The Woodlands, Texas, 77384, United States

Location

Related Publications (2)

  • 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.

    PMID: 39102622DERIVED

  • 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.

    PMID: 37022702DERIVED

Related Links

MeSH Terms

Interventions

Practice Guidelines as TopicStandard of Care

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationQuality Indicators, Health Care

Study Officials

  • Chad Tang

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

July 31, 2018

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations

US(12)