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New treatment option for Pancreatic Cancer
Official title Alpha Radiation Emitters for the Treatment of Pancreatic Cancer for the Treatment of Locally Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT06026943
What this study is testing
- What it's testing
- A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Histologically and/or cytologically proven NCCN locally advanced PC
- Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor...
- DaRT indication validated by a multidisciplinary team.
- Measurable lesion per RECIST (version 1.1) criteria
- TC at Verona's center (not been over a month)
You likely can't join if
- Concomitant chemotherapy or immunotherapy within the past 4 weeks
- Prior radiation therapy to the pancreas
- CA 19-9 \> 1000 Units/ml
- Fit for surgical exploration unless the patient refuses surgery
- Known hypersensitivity to any of the components of the treatment.
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
See the full eligibility criteria
- Histologically and/or cytologically proven NCCN locally advanced PC
- Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery, or the patient...
- DaRT indication validated by a multidisciplinary team.
- Measurable lesion per RECIST (version 1.1) criteria
- TC at Verona's center (not been over a month)
- Lesion size ≤ 5 cm in the longest diameter
- Age ≥18 years old
- ECOG Performance Status Scale ≤ 2
- Life expectancy is more than 6 months
- WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
- Platelet count ≥60,000/μl
- Calculated or measured creatinine clearance ≥ 30cc/min. Calculated or measured creatinine clearance can be ≥ 40cc/min given stability of creatinine levels over the past three weeks (at least 1 test per week).
- AST and ALT ≤ 2.5 X upper limit of normal (ULN)
- INR \< 1.4 for patients not on Warfarin
- people are willing and able to sign an informed consent form
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after...
- Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
- Concomitant chemotherapy or immunotherapy within the past 4 weeks
- Prior radiation therapy to the pancreas
- CA 19-9 \> 1000 Units/ml
- Fit for surgical exploration unless the patient refuses surgery
- Known hypersensitivity to any of the components of the treatment.
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension...
- Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy (not including cholangitis) or a known psychiatric or substance abuse disorder(s) that would...
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative...
- Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
- Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
- Volunteers participating in another treatment study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
- High probability of protocol non-compliance (in opinion of investigator).
- Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.
The study team makes the final eligibility decision.
Where it's taking place
- Verona, Italy
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 - 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 to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Verona, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.