BridgeMD
New treatment option for Locally Advanced Pancreatic Ductal Adenocarcinoma (PDA)
Official title Adaptive Radiation for Locally Advanced Unresectable Pancreatic Cancer
ClinicalTrials.gov ID: NCT06984562
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if Adaptive Radiation Therapy (ART) is safe and effective in treating patients with locally advanced pancreatic cancer. The main questions the study aims to answer are: Can ART improve how well radiation therapy targets the most aggressive cancer cells, while protecting the healthy tissue around the tumor?
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
- Patients must have histologically or cytologically-confirmed PDA.
- Patients must have locally advanced unresectable PDA.
- This includes the following- per NCCN criteria\ : 2.1 Unreconstructible involvement with the superior mesenteric vein or portal vein due to tumor or...
- Patients enrolled onto the dose escalation arm may have started chemotherapy prior to initiation of radiation therapy and the last dose of...
- Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.
You likely can't join if
- Radiologically or cytologically confirmed metastatic disease.
- Patients who have had any prior radiation therapy for pancreatic cancer.
- Patients who have had prior chemoradiation to an overlapping volume.
- Patients with adenosquamous carcinoma of the pancreas.
- people who have had chemotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents...
- Concurrent non-study chemotherapy or biologic therapy.
See the full eligibility criteria
- Patients must have histologically or cytologically-confirmed PDA.
- Patients must have locally advanced unresectable PDA.
- This includes the following- per NCCN criteria\ : 2.1 Unreconstructible involvement with the superior mesenteric vein or portal vein due to tumor or bland thrombus OR 2.2 Solid tumor contact with greater than 180...
- Patients enrolled onto the dose escalation arm may have started chemotherapy prior to initiation of radiation therapy and the last dose of chemotherapy must occur at least 2 weeks before start of ART.
- Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.
- Adequate bone marrow, hepatic, renal function:
- ANC ≥ 1,500/µl and PLT ≥ 100,000/µl
- Bilirubin less than 1.5 ULN
- AST and ALT \< 3X ULN
- Serum Creatinine \<1.5X ULN
- Women of childbearing potential must not be pregnant (negative pregnancy test within 72 hours prior to registration). Postmenopausal woman must have been amenorrheal and non-lactating for at least 12 months to be...
- Age ≥ 18 years
- Participants must sign a written informed consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment, tissue sample collections, and follow-up.
- Radiologically or cytologically confirmed metastatic disease.
- Patients who have had any prior radiation therapy for pancreatic cancer.
- Patients who have had prior chemoradiation to an overlapping volume.
- Patients with adenosquamous carcinoma of the pancreas.
- people who have had chemotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier to \< Grade 2. Patients who received...
- Concurrent non-study chemotherapy or biologic therapy.
- A history of ataxia telangiectasia or other documented history of radiation hypersensitivity.
- Includes both bi- and mono-allelic likely pathogenic or pathogenic ATM mutations (VUS is acceptable).
- Serious, active infections requiring treatment with IV antibiotics
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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 - 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?
Study sites include Philadelphia, Pennsylvania, United States. 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.