Oligometastatic Malignant Solid NeoplasmPhase 2NCT03599765
Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor
A Phase 2 study testing Best Practice and Local Consolidation Therapy in people with Oligometastatic Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Malignant Solid Neoplasm
- What is being tested?
- Best Practice and Local Consolidation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 12 sitesUnited States
- Study dates
- 31 Jul 2018to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Community Health Center
Coldwater, Michigan, 49036
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Queen's Medical Center
Honolulu, Hawaii, 96813
M D Anderson Cancer Center
Houston, Texas, 77030
MD Anderson in Katy
Houston, Texas, 77094
Baptist Health Medical Center
Little Rock, Arkansas, 72205
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
MD Anderson League City
Nassau Bay, Texas, 77058
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
MD Anderson in The Woodlands
The Woodlands, Texas, 77384
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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:
- 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
- Oligometastatic Malignant Solid Neoplasm
- Being tested
- Best Practice, Local Consolidation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive routine therapy
Local Consolidation TherapyProcedure or surgery
Also called LCT, Local Consolidative Therapy
Receive LCT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Best Practice; Procedure: Local Consolidation Therapy |
| Arm II (routine therapy) | Experimental | Patients receive routine drug therapy. Patients may later receive LCT at the discretion of doctor. Receives: Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
General descriptive statistics will be computed.
Measured: Up to 1 year
Progression free survival
Measured: Up to 1 year
Time to development of new distant metastases
Measured: Up to 1 year
Overall survival
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start31 Jul 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oligometastatic Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Chad Tang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599765
- Sponsor's protocol ID
- 2018-0349
- Other IDs
- NCI-2018-01469, 2018-0349
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2018
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 39102622Tang 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.
PubMed 37022702
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03599765
- Acronym / sponsor ID
- 2018-0349
- Conditions
- Oligometastatic Malignant Solid Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 380 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (LCT, routine therapy) | Experimental | Other: Best Practice, Procedure: Local Consolidation TherapyPatients 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 (routine therapy) | Experimental | Other: Best PracticePatients receive routine drug therapy. Patients may later receive LCT at the discretion of doctor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive routine therapy | Other | Arm I (LCT, routine therapy), Arm II (routine therapy) |
| Local Consolidation TherapyAlso: LCT, Local Consolidative TherapyReceive LCT | Procedure or surgery | Arm I (LCT, routine therapy) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 39102622Ludmir 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.
- Derived from this study: PubMed 37022702Tang 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.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad Tang principal investigator
M.D. Anderson Cancer Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Best Practice and Local Consolidation Therapy in people with Oligometastatic Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03599765, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.