Extending Outcomes for Pancreas Cancer Patients With Nominal Oligometastatic Disease (EXPAND): A Randomized Phase III Trial

NCT06593431 | Recruiting Phase 3 DMC

• 2 other identifiers: 2024-1159NCI-2024-07461
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pancreas Cancer; Oligometastatic

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year

Study Arms (2)

MDT (Metastasis-Directed Therapy)

EXPERIMENTAL

Patients will be randomized 1:1 to (a) MDT or (b) systemic therapy alone (no MDT).

Radiation: Consolidative Radiation

System Therapy (control)

EXPERIMENTAL

Patients will be randomized 1:1 to (a) MDT or (b) systemic therapy alone (no MDT).

Radiation: Consolidative Radiation

Interventions

Consolidative Radiation RADIATION

Participants will receive treatment through radiation therapy

MDT (Metastasis-Directed Therapy); System Therapy (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Ethan Ludmir, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ethan Ludmir, MD

CONTACT

(713) 825-3169; ebludmir@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 19, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): June 29, 2029
• Study Completion (Estimated): June 29, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)