Pancreas Cancer study: Consolidative Radiation
Official title Extending Outcomes for Pancreas Cancer Patients With Nominal Oligometastatic Disease (EXPAND): A Randomized Phase III Trial
ClinicalTrials.gov ID: NCT06593431
What this study is testing
- What it's testing
- The study wants to see if a multi‑disciplinary treatment can extend the time patients live and stay disease‑free.
- Who it's for
- Adults with pancreatic cancer that has spread to a few spots.
- What's involved
- Participants will receive the treatment plan and have regular visits and tests.
- Time commitment
- The study lasts about 2 years with scheduled visits every few months.
- Phase 3: a large, late-stage study
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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).
- 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...
You likely can't join 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...
- Leptomeningeal disease.
- Peritoneal carcinomatosis.
- Cognitively impaired people (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...
See the full eligibility criteria
- 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).
- 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.
- In patients with a LN exhibiting a short axis ≥15mm and who have other diagnoses that can produce enlarged LNs (e.g.
- 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...
- 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.
- Diagnostic laparoscopy may be indicated prior to enrollment if any concern for peritoneal disease / carcinomatosis is present, at the investigator's discretion.
- 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...
- Patients with \>5 discrete metastatic sites previously with subsequent 'induction' of oligometastatic disease (\<=5 discrete sites
- 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...
- 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.
- 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 people (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.
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Camden, New Jersey, United States
- Voorhees Township, New Jersey, United States
- Dallas, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Camden, New Jersey, United States; Voorhees Township, New Jersey, United States; Dallas, Texas, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.