Phase II study of external irradiation and weekly paclitaxel for nonmetastatic, unresectable pancreatic cancer: RTOG-98-12.
Tyvin Rich, Jonathan Harris, R Abrams...
https://pubmed.ncbi.nlm.nih.gov/14758134Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
ID03652428
Phase I Study of Nab-Paclitaxel and Gemcitabine with Hypofractionated Proton Therapy for Locally Advanced Pancreatic Cancer
Led by University of Maryland, Baltimore · Updated on 2026-05-06
24
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the highest safe dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when given together with a targeted form of radiation called hypofractionated ablative proton therapy for patients with locally advanced pancreatic cancer. This phase I trial aims to find a recommended dose for future studies while reducing side effects by focusing the radiation on the main tumor area and avoiding nearby sensitive organs. Participants will receive proton therapy once a day from Monday to Friday for three weeks, totaling 15 treatment sessions. Chemotherapy with gemcitabine and nab-paclitaxel will be administered once a week on Mondays during these three weeks. After the combined treatment, surgery may be performed if the tumor becomes removable, followed by additional chemotherapy as decided by the doctor. If surgery isn't possible, chemotherapy will continue as recommended by the medical team. During the study, participants will have regular assessments including scans and lab tests to monitor tumor response, side effects, and overall health. Researchers will follow patients for up to 12 months after starting treatment or until death, whichever comes first, to measure the maximum tolerated dose of chemotherapy with radiation, tumor control, survival rates, adverse events, and quality of life. Safety and treatment effects will be closely monitored throughout this period.
CONDITIONS
Brief Title
Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Cytologic or histologic proof of adenocarcinoma of the pancreas
- Nonmetastatic pancreatic cancer without spread to distant lymph nodes or organs
- Tumor involvement preventing surgery due to contact with key arteries or veins
- ECOG Performance Status of 0 or 1 indicating good overall health
- Absolute neutrophil count of 1,000/mm3 or higher
- Platelet count of 100,000/mm3 or higher
- Creatinine level less than or equal to 1.5 times the upper normal limit
- Creatinine clearance greater than 45 mL/min
- Total bilirubin level less than or equal to 2 mg/dL
You will not qualify if you...
- Resectable or borderline resectable pancreatic cancer
- Prior definitive pancreatic cancer surgery
- Prior abdominal radiation overlapping study treatment area
- Prior chemotherapy except for specified regimens (FOLFIRINOX, Gem-Abrax, Gem-Cap)
- Grade 4 toxicity from prior chemotherapy
- More than two dose reductions during induction chemotherapy
- Ongoing treatment with strong CYP3A4 inhibitors or inducers without discontinuation 14 days before study
- Baseline grade 2 or higher neuropathy, known Gilbert's disease, or specific genetic polymorphisms
- Pregnancy or breastfeeding
- Known HIV infection on combination antiretroviral therapy
- Non-compliance with induction chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 weeks
Participants receive concurrent chemotherapy with gemcitabine and nab-paclitaxel along with hypofractionated ablative proton therapy targeting the pancreatic tumor.
Weekly visits for chemotherapy and daily visits Monday through Friday for proton therapy over 3 weeks
Follow-up
Duration - Up to 12 months
Participants are monitored for safety, tumor response, quality of life, and survival outcomes after completing treatment.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 2 locations
1
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
University of Maryland Medical Center/Maryland Proton Treatment Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
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Research Team
J
Jason Molitoris, MD
J
Jasmine A Newman, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Toxicity and efficacy of concurrent gemcitabine and radiotherapy for locally advanced pancreatic cancer.
C H Crane, N A Janjan, D B Evans...
https://pubmed.ncbi.nlm.nih.gov/11560155Focal Radiation Therapy Dose Escalation Improves Overall Survival in Locally Advanced Pancreatic Cancer Patients Receiving Induction Chemotherapy and Consolidative Chemoradiation.
Sunil Krishnan, Awalpreet S Chadha, Yelin Suh...
https://pubmed.ncbi.nlm.nih.gov/26972648