Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor
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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 : December 8, 2022
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Condition or disease | Intervention/treatment | Phase |
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Oligometastatic Malignant Solid Neoplasm | Other: Best Practice Procedure: Local Consolidation Therapy | Phase 2 |
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 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, 2025 |
Estimated Study Completion Date : | December 31, 2025 |
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.
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Other: Best Practice
Receive routine therapy
Other Names:
Procedure: Local Consolidation Therapy Receive LCT
Other Names:
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Experimental: Arm II (routine therapy)
Patients receive routine drug therapy. Patients may later receive LCT at the discretion of doctor.
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Other: Best Practice
Receive routine therapy
Other Names:
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- Incidence of adverse events [ Time Frame: Up to 1 year ]General descriptive statistics will be computed.
- Progression free survival [ Time Frame: Up to 1 year ]
- Time to development of new distant metastases [ Time Frame: Up to 1 year ]
- Overall survival [ Time Frame: Up to 1 year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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
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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)

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
Contact: Chad Tang | 713-563-2300 | ctang1@mdanderson.org |
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 |
Principal Investigator: | Chad Tang | M.D. Anderson Cancer Center |
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: | December 8, 2022 |
Last Verified: | December 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |