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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03599765
Collaborator
National Cancer Institute (NCI) (NIH)
367
Enrollment
13
Locations
2
Arms
53
Anticipated Duration (Months)
28.2
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Procedure: Local Consolidation Therapy
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:

  1. In patients with oligometastatic malignancies, to assess overall survival (OS) with upfront LCT vs. no LCT among randomized patients.

  2. In patients with oligometastatic malignancies, to assess time to next line systemic therapy with upfront LCT vs. no LCT.

  3. In patients with oligometastatic malignancies, to assess time to new lesion failure with upfront LCT vs. no LCT.

  4. To assess safety/tolerability of upfront LCT in patients with oligometastatic malignancies.

  5. In patients with oligometastatic malignancies, to assess quality of life with upfront LCT vs. no LCT.

EXPLORATORY OBJECTIVES:

  1. To identify predictive/prognostic biomarkers that are associated with a benefit to LCT across disease sites.

  2. To investigate the systemic immune activating effects of radiation.

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
367 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
External Beam Radiation to Eliminate Nominal Metastatic Disease (EXTEND): A Randomized Phase II Basket Trial Assessing the Efficacy of Upfront Local Consolidative Therapy (LCT) for Oligometastatic Disease
Actual Study Start Date :
Jul 31, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Best Practice
Receive routine therapy
Other Names:
  • standard of care
  • standard therapy

    • Procedure: Local Consolidation Therapy
    Receive LCT
    Other Names:
  • LCT
  • Local Consolidative Therapy

    		•
    Experimental: Arm II (routine therapy)

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

    Other: Best Practice
    Receive routine therapy
    Other Names:
  • standard of care
  • standard therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events [Up to 1 year]

      General descriptive statistics will be computed.

    2. Progression free survival [Up to 1 year]

    3. Time to development of new distant metastases [Up to 1 year]

    4. Overall survival [Up to 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lewis and Faye Manderson Cancer Center Tuscaloosa Alabama United States 35401
    2 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    3 Baptist Health Medical Center Little Rock Arkansas United States 72205
    4 Queen's Medical Center Honolulu Hawaii United States 96813
    5 Community Health Center Coldwater Michigan United States 49036
    6 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    7 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
    8 M D Anderson Cancer Center Houston Texas United States 77030
    9 MD Anderson in Katy Houston Texas United States 77094
    10 MD Anderson League City Nassau Bay Texas United States 77058
    11 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    12 MD Anderson in Sugar Land Sugar Land Texas United States 77478
    13 MD Anderson in The Woodlands The Woodlands Texas United States 77384

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Chad Tang, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03599765
    Other Study ID Numbers:
    • 2018-0349
    • NCI-2018-01469
    • 2018-0349
    First Posted:
    Jul 26, 2018
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 14, 2022