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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03599765
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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
Oligometastatic Malignant Solid Neoplasm Other: Best Practice Procedure: Local Consolidation Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

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

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

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.

EXPLORATORY OBJECTIVES:

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

II. 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 31, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 1 year ]
    General descriptive statistics will be computed.

  2. Progression free survival [ Time Frame: Up to 1 year ]
  3. Time to development of new distant metastases [ Time Frame: Up to 1 year ]
  4. Overall survival [ Time Frame: Up to 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599765


Contacts
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Contact: Chad Tang 713-563-2300 ctang1@mdanderson.org

Locations
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United States, Alabama
Lewis and Faye Manderson Cancer Center Not yet recruiting
Tuscaloosa, Alabama, United States, 35401
Contact: James C. Tucker       jctucker@oawa.net   
Principal Investigator: James C. Tucker         
United States, Arizona
Banner MD Anderson Cancer Center Not yet recruiting
Gilbert, Arizona, United States, 85234
Contact: Gary V. Walker       gary.walker@bannerhealth.com   
Principal Investigator: Gary V. Walker         
United States, Arkansas
Baptist Health Medical Center Not yet recruiting
Little Rock, Arkansas, United States, 72205
Contact: Michael R. Olson       Michael.olson@bmcjax.com   
Principal Investigator: Michael R. Olson         
United States, Hawaii
Queen's Medical Center Not yet recruiting
Honolulu, Hawaii, United States, 96813
Contact: Stuart Y. Tsuji       stsuji@queens.org   
Principal Investigator: Stuart Y. Tsuji         
United States, Michigan
Community Health Center Not yet recruiting
Coldwater, Michigan, United States, 49036
Contact: Daniel W. Weed       dweed@ecommunity.com   
Principal Investigator: Daniel W. Weed         
United States, New Jersey
Cooper Hospital University Medical Center Not yet recruiting
Camden, New Jersey, United States, 08103
Contact: Megan A. Mezera       mezera-megan@cooperhealth.edu   
Principal Investigator: Megan A. Mezera         
United States, Ohio
OhioHealth Mansfield Hospital Not yet recruiting
Mansfield, Ohio, United States, 44903
Contact: Andrew B. Freeman       andrew.freeman@ohiohealth.com   
Principal Investigator: Andrew B. Freeman         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Chad Tang    713-563-2300      
Principal Investigator: Chad Tang         
MD Anderson in Katy Not yet recruiting
Houston, Texas, United States, 77094
Contact: Stephen G. Chun    713-563-2300      
Principal Investigator: Stephen G. Chun         
MD Anderson League City Not yet recruiting
Nassau Bay, Texas, United States, 77058
Contact: Stephen G. Chun    713-563-2300      
Principal Investigator: Stephen G. Chun         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Mohamad H. Fakhreddine    210-450-5652    fakhreddine@uthscsa.edu   
Principal Investigator: Mohamad H. Fakhreddine         
MD Anderson in Sugar Land Not yet recruiting
Sugar Land, Texas, United States, 77478
Contact: Stephen G. Chun    713-563-2300      
Principal Investigator: Stephen G. Chun         
MD Anderson in The Woodlands Not yet recruiting
The Woodlands, Texas, United States, 77384
Contact: Stephen G. Chun    713-563-2300      
Principal Investigator: Stephen G. Chun         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Chad Tang M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03599765    
Other Study ID Numbers: 2018-0349
NCI-2018-01469 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0349 ( Other Identifier: M D Anderson Cancer Center )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No