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Anti-metabolites

Chemotherapy + Proton Therapy for Pancreatic Cancer

Phase 1 & 2
Recruiting
Led By Jason Molitoris, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cytologic or histologic proof of adenocarcinoma of the pancreas
Unequivocal radiographic findings contraindicating resection including, but not limited to, solid tumor contact with specific anatomical structures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be followed for 12 months after registration or until death, whichever occurs first.
Awards & highlights

Study Summary

This trial is testing a new way to give proton therapy and chemotherapy for pancreatic cancer.

Who is the study for?
This trial is for adults with nonmetastatic pancreatic cancer that can't be surgically removed. They should have good physical function (able to carry out daily activities) and adequate blood counts, kidney, and liver functions. Pregnant or breastfeeding individuals, those who've had certain prior treatments or surgeries for pancreatic cancer, or have specific genetic conditions are excluded.Check my eligibility
What is being tested?
The study aims to find the highest dose of nab-paclitaxel and gemcitabine chemotherapy drugs that's safe when given with a type of targeted radiation called hypofractionated ablative proton therapy over three weeks to treat advanced pancreatic cancer.See study design
What are the potential side effects?
Potential side effects include reactions from chemotherapy like nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems; skin changes from radiation; and possible damage to nearby organs due to the precision of proton therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is pancreatic adenocarcinoma.
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My scans show my tumor can't be surgically removed due to its location.
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I am fully active or can carry out light work.
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My pancreatic cancer has not spread to distant areas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed for 12 months after registration or until death, whichever occurs first.
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed for 12 months after registration or until death, whichever occurs first. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose of Gemcitabine and nab-Paclitaxel in LAPC patients receiving proton therapy
Secondary outcome measures
Median Overall Survival of Patients
Number of adverse events/toxicites reported during and following treatment of concurrent nab-paclitaxel + gemcitabine combined with hypofractionated ablative proton therapy
Primary Tumor Response in LAPC patients receiving proton therapy with concurrent Gemcitabine and nab-Paclitaxel
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pancreatic Proton Therapy With Concurrent Gem + Nab-paclitaxelExperimental Treatment2 Interventions
Part I: Gemcitabine + nab-paclitaxel: • Administered per institutional standard every 7 days for 3 weeks Part II: Hypofractionated ablative pancreatic proton radiation therapy 67.5 Gy fractions once per day Monday - Friday for 3 weeks, for a total of 15 fractions. Part III: Surgery, if resectable, then adjuvant chemo per discretion of MD or no further therapy OR Chemo per discretion of MD if not resectable
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
685 Previous Clinical Trials
373,022 Total Patients Enrolled
Jason Molitoris, MDPrincipal InvestigatorUniversity of Maryland/Maryland Proton Treatment Center
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03652428 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Pancreatic Proton Therapy With Concurrent Gem + Nab-paclitaxel
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT03652428 — Phase 1 & 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03652428 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment to this clinical trial open to elderly individuals?

"This medical research seeks individuals aged 18 or older, but under the age of 75."

Answered by AI

Is enrollment open for this clinical trial at present?

"According to clinicaltrials.gov, this medical investigation is currently seeking participants. The experiment was initially made public on April 2nd 2019 and further updated October 10th 2022."

Answered by AI

How many participants are engaged with this experiment?

"Affirmative, the details on clinicaltrials.gov demonstrate that this experiment is currently recruiting volunteers. Initially posted on April 2nd 2019 and updated October 10th 2022, 24 individuals are being sought after from two separate medical facilities."

Answered by AI

Have any other trials elucidated the efficacy of this remedy?

"This form of treatment first gained attention in 1997, as City of Hope Comprehensive Cancer Center began studying it. After over two decades of research, there are 1857 completed trials thus far and 1113 ongoing studies; a significant amount being hosted out of Baltimore, Maryland."

Answered by AI

Who satisfies the eligibility criteria for this experiment?

"This trial has a specific set of requirements that must be met. These include having cancer of the pancreas and being between 18-75 years old. Aiming to recruit 24 individuals, this research is now accepting applications."

Answered by AI

What afflictions are usually ameliorated by this therapy?

"This remedy is often prescribed for the treatment of cancer metastasis. Additionally, it may also be effective in treating localized non-small cell lung cancer, bladder cancer and malignancies that affect the urinary tract."

Answered by AI
Recent research and studies
~6 spots leftby Dec 2025