OligoProgressive Metastatic DiseasePhase 2/3NCT06367972
A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP)
A Phase 2/3 study testing Local Consolidation Therapy and Next-line Systemic Therapy in people with OligoProgressive Metastatic Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To find out if local consolidation therapy (such as radiation therapy with or without other local therapies such as surgery, ablation [the removal or destruction of a body part or tissue or its function], or embolization [a procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel])… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OligoProgressive Metastatic Disease
- What is being tested?
- Local Consolidation Therapy and Next-line Systemic Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2024to 10 Oct 2030
- Phase
- Phase 2/3
- 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
- Age ≥18
- Histologically or cytologically confirmed stage IV cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Candidate for LCT (radiation therapy +/- other local therapies such as surgery, ablation, or embolization) to all sites of progressive disease.
- Progressive disease will be defined as a discrete radiologic lesion that has not received prior local therapy. Progressive disease will be defined as RECIST (v1.1) defined progression from pre-baseline imaging to baseline imaging at time of screening for the trial.
- Progressive disease must represent an active lesion, which may be defined as the primary tumor site, regional nodal disease, and/or distant metastatic sites.
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- Candidate for radiation therapy to at least one site of disease.
- Between one and five progressive lesions, counted as follows: each lesion (not site) will be counted as one, with the exception of metastatic lymph node stations, which will collectively count as one lesion. Regional nodal stations will be counted as a collective single lesion if oligoprogressive. All progressive lesions must be amenable to local therapy as noted in criterion 4.2.1.5 above.
- Counting of oligoprogressive nodal disease will be based on nodal chains. A nodal chain will be considered a single metastatic lesion if the presence of that node results in the patient as having M1 disease per the TNM staging system, AJCC version 8.0. In addition, one of the following criteria must be met: a) ≥1 LN meets radiologic criteria for metastatic disease via RECIST 1.1 (short axis ≥15mm), b) pathologic assessment has confirmed the presence of metastatic cancer cells, and/or c) the LN exhibits imaging signal characteristic of a metastatic lesion (e.g. FDG avidity, contrast enhancement, etc…). In the event of ambiguity, a study co-Investigator will make a final determination of whether pathologic criteria are met. The following caveats apply:
- In participants with a LN exhibiting a short axis ≥15mm and who have other diagnoses that can produce enlarged LNs (e.g. indolent CLL, sarcoidosis, etc…) or a prior history of benign enlarged LNs will not be considered to have metastatic disease per the discretion of the treating physician.
- LN chains that occur bilaterally will be considered separate metastatic sites. For example, left axilla LNs will counted separately from right axilla LNs.
- The following midline LN chains will be counted as 1 metastatic site: mediastinal, para-aortic, mesenteric.
- The following bilateral LN chains will be counted as 1 metastatic site for unilateral involvement, and 2 for bilateral for involvement: preauricular, cervical and occipital, supraclavicular, infraclavicular, pectoral, axillary, hilar, epitrochlear and brachial, iliac, inguinal and femoral, popliteal.
- Baseline imaging must include a scan done within 4 weeks prior to randomization, demonstrating oligoprogressive disease by RECIST (v1.1) criteria compared to pre-baseline imaging.
- Baseline imaging must be done within 4 weeks prior to randomization, and the following imaging is required: PET/CT scan or CT scan of the chest/abdomen/pelvis. MRI may be substituted as indicated (i.e., CT scan of chest plus MRI abdomen/pelvis). Intracranial imaging is recommended for those histologies/disease sites where intracranial restaging is routinely recommended or appropriate as part of staging/restaging standard-of-care.
- Pre-baseline imaging must be done 6-16 weeks prior to baseline imaging, and it is recommended to have a comparable imaging modality (matched modalities between pre-baseline and baseline imaging). RECIST v1.1 will be utilized to define any progressive sites of disease, and if between 1 and 5 RECIST-defined progressive sites of disease are identified, participant may be eligible. Non-RECIST-eligible lesions may be eligible if radiographic and/or clinical features support this lesion being progressive.
- Participants referred for the study that require immediate LCT can receive treatment to CNS lesions or other symptomatic lesions prior to randomization, but these lesions will be counted towards the total number of oligoprogressive lesions.
- Has one of the following 7 histologic types (metastatic disease): colorectal carcinoma (CRC), renal cell carcinoma (RCC), breast cancer, pancreatic cancer, urothelial (bladder) cancer, prostate cancer, and esophageal cancer.
- Females of childbearing potential must not be breast feeding and must have a negative serum or urine pregnancy test and must agree to use adequate contraception from the time of screening until 3 months after discontinuation of the study medication. Acceptable methods of contraception include total and true sexual abstinence, tubal ligation, hormonal contraceptives that are not prone to drug-drug interactions (IUS Levonorgestrel Intra Uterine System (Mirena), Medroxyprogesterone injections (Depo-Provera)), copper-banded intra-uterine devices, and vasectomized partner. All hormonal methods of contraception should be used in combination with the use of a condom by their sexual male partner. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Women will be considered post-menopausal if they have been amenorrheic for the past 12 months without an alternative medical cause. The following age-specific requirements must also apply: Women < 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of exogenous hormonal treatments. The levels of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) must also be in the post-menopausal range (as per the institution). Women ≥ 50 years old: they would be consider post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of all exogenous hormonal treatments, or have had radiation-induced oophorectomy with the last menses > 1 year ago, or have had chemotherapy-induced menopause with >1 year interval since last menses, or have had surgical sterilization by either bilateral oophorectomy or hysterectomy.
- Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study and 3 month after the last dose of study medication. Adequate contraception methods include: birth control pills (eg combined oral contraceptive pill), barrier protection (eg condom plus spermicide, cervical/vault cap or intrauterine device), and abstinence. Participants should not father a child for 6 months after completion of the study medication. Participants should refrain from donating sperm from the start of dosing until 6 months after discontinuing the study medication. If male participants wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of the study medication.
- Demonstration of adequate organ function as defined in the table below, all screening labs to be performed within 4 weeks prior to study enrollment:
- Table of Adequate Organ Function Laboratory Values System Laboratory Value Hematological Absolute neutrophil count (ANC) = ≥500 /mcL Platelets = ≥25,000 / mcL Hemoglobin = ≥7 g/dL Hepatic 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 ≤ ULN for subjects with total bilirubin levels > 1.5 mg/dl AST (SGOT) and ALT (SGPT) = ≤ 3 X ULN OR ≤ 5 X ULN for subjects with liver metastases
Who cannot join
- Metastatic effusion (e.g. pleural effusion or ascites). Note that participants with an effusion that is too small to sample will be eligible for the trial.
- Leptomeningeal disease.
- Peritoneal carcinomatosis.
- Cognitively impaired subjects (e.g. inability to sign informed consent.)
- Any condition that, in the opinion of the investigator, would interfere with the study treatment or interpretation of the study results.
- Diffuse bone marrow involvement as defined by disease involvement of a BM biopsy from a site that does not have radiologic evidence of a bone metastasis.
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- More than 4 prior lines of systemic therapy to treat metastatic disease.
- Diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe delivery of radiotherapy.
- Known psychiatric or substance abuse disorder/s that would interfere with trial participation.
- Concurrent (synchronous or metachronous) other primary malignancy that in the opinion of the treating physician team presents a substantial risk to the participant's life as a competing risk of death (against the primary oligoprogressive malignancy being considered for LCT as part of this trial).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Ethan Ludmir, MD, 832-729-0998, ebludmir@mdanderson.org
Ethan Ludmir, MD
About this study
To find out if local consolidation therapy (such as radiation therapy with or without other local therapies such as surgery, ablation [the removal or destruction of a body part or tissue or its function], or embolization [a procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel]) to all progressive sites of disease can help to control the disease compared with next-line systemic therapy.
Read the detailed description
Primary Objective:
- To determine whether, in participants with oligoprogressive metastatic disease, LCT to all progressive sites of disease offers a benefit in PFS compared to NLST, across seven tumor types in a basket design.
Secondary Objectives:
- To determine whether LCT improves OS in participants with oligoprogressive disease across seven tumor types.
- To assess safety/tolerability of LCT in participants with oligometastatic disease in tumor subtypes.
- To compare quality of life (QOL) of LCT vs. next-line systemic therapy in participants with oligoprogressive disease.
- To characterize duration and progression-free survival time of participants on same-line systemic therapy (SLST) after LCT in the experimental arm.
- To identify predictive/prognostic biomarkers correlated with a benefit for LCT across tumor types, with the aim being to incorporate these biomarkers into future clinical trials.
- Conditions
- OligoProgressive Metastatic Disease
- Being tested
- Local Consolidation Therapy, Next-line Systemic Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Consolidation TherapyProcedure or surgery
Also called LCT
Participants may receive radiation therapy. The choice of LCT and radiation therapy regimen will be determined by a multidisciplinary team including the study doctor.
Next-line Systemic TherapyProcedure or surgery
Also called NLST
The specific next-line systemic therapy will be determined by your doctor.
| Study group | Role | What they receive |
|---|---|---|
| NLST Arm | Experimental | Participants are assigned to Group 1, participants will be treated with next-line systemic therapy. The specific next-line systemic therapy will be determined by your doctor.
- If progression occurs (the disease gets worse), participants may cross over to Group 2 and receive LCT. Receives: Procedure: Next-line Systemic Therapy |
| LCT Arm | Experimental | Participants are assigned to Group 2, participants will be treated with LCT and then continue on same systemic therapy participants have been receiving followed by the next line systemic of therapy (if applicable). The specific treatments will be determined by your doctor. Receives: Procedure: Local Consolidation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start6 Jun 2024
- Primary completion10 Oct 2028 (estimated)
- Study completion10 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligoProgressive Metastatic DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ethan Ludmir, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367972
- Sponsor's protocol ID
- 2024-0070
- Other IDs
- NCI-2024-03278
- Status last verified
- Jun 2026
- First submitted
- 11 Apr 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP)
- ClinicalTrials.gov ID
- NCT06367972
- Acronym / sponsor ID
- 2024-0070
- Conditions
- OligoProgressive Metastatic Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 10 Oct 2028 (estimated)
- Study completion
- 10 Oct 2030 (estimated)
- First posted
- 16 Apr 2024 (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.
To find out if local consolidation therapy (such as radiation therapy with or without other local therapies such as surgery, ablation [the removal or destruction of a body part or tissue or its function], or embolization [a procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel]) to all progressive sites of disease can help to control the disease compared with next-line systemic therapy.
Detailed description
Primary Objective:
- To determine whether, in participants with oligoprogressive metastatic disease, LCT to all progressive sites of disease offers a benefit in PFS compared to NLST, across seven tumor types in a basket design.
Secondary Objectives:
- To determine whether LCT improves OS in participants with oligoprogressive disease across seven tumor types.
- To assess safety/tolerability of LCT in participants with oligometastatic disease in tumor subtypes.
- To compare quality of life (QOL) of LCT vs. next-line systemic therapy in participants with oligoprogressive disease.
- To characterize duration and progression-free survival time of participants on same-line systemic therapy (SLST) after LCT in the experimental arm.
- To identify predictive/prognostic biomarkers correlated with a benefit for LCT across tumor types, with the aim being to incorporate these biomarkers into future clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NLST Arm | Experimental | Procedure: Next-line Systemic TherapyParticipants are assigned to Group 1, participants will be treated with next-line systemic therapy. The specific next-line systemic therapy will be determined by your doctor. - If progression occurs (the disease gets worse), participants may cross over to Group 2 and receive LCT. |
| LCT Arm | Experimental | Procedure: Local Consolidation TherapyParticipants are assigned to Group 2, participants will be treated with LCT and then continue on same systemic therapy participants have been receiving followed by the next line systemic of therapy (if applicable). The specific treatments will be determined by your doctor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥18
- Histologically or cytologically confirmed stage IV cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Candidate for LCT (radiation therapy +/- other local therapies such as surgery, ablation, or embolization) to all sites of progressive disease.
- Progressive disease will be defined as a discrete radiologic lesion that has not received prior local therapy. Progressive disease will be defined as RECIST (v1.1) defined progression from pre-baseline imaging to baseline imaging at time of screening for the trial.
Key exclusion criteria (10 listed)
- Metastatic effusion (e.g. pleural effusion or ascites). Note that participants with an effusion that is too small to sample will be eligible for the trial.
- Leptomeningeal disease.
- Peritoneal carcinomatosis.
- Cognitively impaired subjects (e.g. inability to sign informed consent.)
- Any condition that, in the opinion of the investigator, would interfere with the study treatment or interpretation of the study results.
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 |
|---|---|---|
| Local Consolidation TherapyAlso: LCTParticipants may receive radiation therapy. The choice of LCT and radiation therapy regimen will be determined by a multidisciplinary team including the study doctor. | Procedure or surgery | LCT Arm |
| Next-line Systemic TherapyAlso: NLSTThe specific next-line systemic therapy will be determined by your doctor. | Procedure or surgery | NLST Arm |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 11 Jun 2026.
- MD Anderson Cancer CenterLink 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.
Ethan Ludmir principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Local Consolidation Therapy and Next-line Systemic Therapy in people with OligoProgressive Metastatic Disease, run by M.D. Anderson Cancer Center at 1 site 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 22 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 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 1 site 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Ethan Ludmir, MD ((832) 729-0998, ebludmir@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026.