Pancreas CancerPhase 3NCT06593431
Extending Outcomes for Pancreas Cancer Patients With Nominal Oligometastatic Disease (EXPAND): A Randomized Phase III Trial
A Phase 3 study testing Consolidative Radiation in people with Pancreas Cancer and Oligometastatic, run by M.D. Anderson Cancer Center at 4 sites in United States.
Trial summary
The EXPAND trial (EXtending outcomes for PAncreas cancer patients with Nominal oligometastatic Disease) is a randomized phase III trial assessing the efficacy of MDT to improve PFS and OS for patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Oligometastatic
- What is being tested?
- Consolidative Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Oct 2024to 29 Jun 2029
- Phase
- Phase 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 pancreatic ductal adenocarcinoma.
- Histologic / cytologic confirmation of pancreatic ductal adenocarcinoma may come from the primary tumor (i.e., via FNA at initial diagnosis). Histological/pathologic confirmation of distant metastatic disease is not required if clinical and radiographic consensus is that the patient has distant metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Candidate for MDT (including radiation therapy, surgical resection, ablation, and embolization) to all sites of disease including oligometastatic sites and if present intact primary / regional nodal disease.
- Between one and five distant metastatic 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 present. All progressive lesions must be amenable to local therapy as noted in criterion 4.2.1.4 above.
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- Counting of oligometastatic 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 or equivocal findings, the principal investigator or co-principal investigator will make a final determination of whether criteria are met. The following caveats apply:
- In patients 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 oligometastatic 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).
- Diagnostic laparoscopy may be indicated prior to enrollment if any concern for peritoneal disease / carcinomatosis is present, at the investigator's discretion. Presence of peritoneal carcinomatosis will exclude the patient from this trial as below. Indications for peritoneal carcinomatosis may include findings concerning for but not definitive for peritoneal disease on diagnostic imaging, elevated CA-19-9, and clinical symptoms concerning for peritoneal disease.
- Patients referred for the study that require immediate MDT can receive treatment to CNS lesions or other symptomatic lesions prior to randomization, but these lesions will be counted towards the total number of oligometastatic lesions.
- Patients with \>5 discrete metastatic sites previously with subsequent 'induction' of oligometastatic disease (\<=5 discrete sites; induction via response to systemic therapy) may be eligible if 5 or fewer metastatic disease sites have been present / noted radiographically for a minimum of 6 months, and pending principal investigator review/discretion.
- 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 6 months after the last dose of study medication. Adequate contraception methods include: birth control pills (e.g. combined oral contraceptive pill), barrier protection (e.g. condom plus spermicide, cervical/vault cap or intrauterine device), and abstinence. Patients should not father a child for 6 months after completion of the study medication. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing the study medication. If male patients 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:
Who cannot join
- 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.
- 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. Such patients may be eligible if dispositioned to non-radiotherapy MDT.
- 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 patient's life as a competing risk of death (against the primary oligometastatic pancreatic cancer being considered for MDT as part of this trial).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Megan Mezera, MD, mezera-megan@cooperhealth.edu
Megan Mezera, MD
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Todd Aguilera, MD, 214-645-8525, todd.aguilera@utsouthwestern.edu
Todd Aguilera, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Ethan Ludmir, MD, 713-825-3169, ebludmir@mdanderson.org
Ethan Ludmir, MD
- Recruiting
Cooper Hospital University Medical Center
Voorhees Township, New Jersey, 08043
Megan Mezera, MD, mezera-megan@cooperhealth.edu
Megan Mezera, MD
About this study
The EXPAND trial (EXtending outcomes for PAncreas cancer patients with Nominal oligometastatic Disease) is a randomized phase III trial assessing the efficacy of MDT to improve PFS and OS for patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC).
Read the detailed description
Primary Objectives:
To determine whether, in patients with oligometastatic pancreatic ductal adenocarcinoma, MDT to all sites of disease confers a benefit in PFS compared to systemic therapy alone.
Secondary Objectives:
Key secondary objective: To determine whether, in patients with oligometastatic pancreatic ductal adenocarcinoma, MDT to all sites of disease confers a benefit in OS compared to systemic therapy alone.
To assess safety/tolerability of MDT in patients with oligometastatic PDAC.
To assess time to new lesion formation between treatment arms.
To assess time to next-line systemic therapy between treatment arms.
To assess incidence and duration of time off systemic therapy between treatment arms.
To assess incidence and duration of time on maintenance systemic therapy between treatment arms.
To assess time to local failure between treatment arms for lesions present at enrollment/baseline.
To compare quality of life (QOL) between treatment arms.
To assess the above primary and secondary objectives, as well as exploratory objectives, which may be differential based on receipt of different forms of MDT in the MDT arm (e.g,. surgery, external beam radiotherapy, etc).
Exploratory Objectives:
To identify predictive/prognostic biomarkers correlated with a benefit for MDT.
To investigate changes in biomarker profile over time and in response to MDT.
- Conditions
- Pancreas Cancer, Oligometastatic
- Being tested
- Consolidative Radiation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consolidative RadiationRadiation
Participants will receive treatment through radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| MDT (Metastasis-Directed Therapy) | Experimental | Patients will be randomized 1:1 to (a) MDT or (b) systemic therapy alone (no MDT). Receives: Radiation: Consolidative Radiation |
| System Therapy (control) | Experimental | Patients will be randomized 1:1 to (a) MDT or (b) systemic therapy alone (no MDT). Receives: Radiation: Consolidative Radiation |
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 posted19 Sep 2024
- Study start23 Oct 2024
- Primary completion29 Jun 2029 (estimated)
- Study completion29 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ethan Ludmir, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593431
- Sponsor's protocol ID
- 2024-1159
- Other IDs
- NCI-2024-07461
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2024
- Last updated
- 6 Oct 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extending Outcomes for Pancreas Cancer Patients With Nominal Oligometastatic Disease (EXPAND): A Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT06593431
- Acronym / sponsor ID
- 2024-1159
- Conditions
- Pancreas Cancer, Oligometastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 29 Jun 2029 (estimated)
- Study completion
- 29 Jun 2029 (estimated)
- First posted
- 19 Sep 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.
The EXPAND trial (EXtending outcomes for PAncreas cancer patients with Nominal oligometastatic Disease) is a randomized phase III trial assessing the efficacy of MDT to improve PFS and OS for patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC).
Detailed description
Primary Objectives:
To determine whether, in patients with oligometastatic pancreatic ductal adenocarcinoma, MDT to all sites of disease confers a benefit in PFS compared to systemic therapy alone.
Secondary Objectives:
Key secondary objective: To determine whether, in patients with oligometastatic pancreatic ductal adenocarcinoma, MDT to all sites of disease confers a benefit in OS compared to systemic therapy alone.
To assess safety/tolerability of MDT in patients with oligometastatic PDAC.
To assess time to new lesion formation between treatment arms.
To assess time to next-line systemic therapy between treatment arms.
To assess incidence and duration of time off systemic therapy between treatment arms.
To assess incidence and duration of time on maintenance systemic therapy between treatment arms.
To assess time to local failure between treatment arms for lesions present at enrollment/baseline.
To compare quality of life (QOL) between treatment arms.
To assess the above primary and secondary objectives, as well as exploratory objectives, which may be differential based on receipt of different forms of MDT in the MDT arm (e.g,. surgery, external beam radiotherapy, etc).
Exploratory Objectives:
To identify predictive/prognostic biomarkers correlated with a benefit for MDT.
To investigate changes in biomarker profile over time and in response to MDT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDT (Metastasis-Directed Therapy) | Experimental | Radiation: Consolidative RadiationPatients will be randomized 1:1 to (a) MDT or (b) systemic therapy alone (no MDT). |
| System Therapy (control) | Experimental | Radiation: Consolidative RadiationPatients will be randomized 1:1 to (a) MDT or (b) systemic therapy alone (no MDT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
- Histologic / cytologic confirmation of pancreatic ductal adenocarcinoma may come from the primary tumor (i.e., via FNA at initial diagnosis). Histological/pathologic confirmation of distant metastatic disease is not required if clinical and radiographic consensus is that the patient has distant metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Candidate for MDT (including radiation therapy, surgical resection, ablation, and embolization) to all sites of disease including oligometastatic sites and if present intact primary / regional nodal disease.
Key exclusion criteria (10 listed)
- 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.
- 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 |
|---|---|---|
| Consolidative RadiationParticipants will receive treatment through radiation therapy | Radiation | MDT (Metastasis-Directed Therapy), System Therapy (control) |
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 6 Oct 2026.
- 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.
Ethan Ludmir, MD principal investigator
M.D. Anderson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Consolidative Radiation in people with Pancreas Cancer and Oligometastatic, run by M.D. Anderson Cancer Center at 4 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 19 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 ((713) 825-3169, 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 6 Oct 2026.