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2024-03-15
2027-01-31
2028-01-31
60
NCT06233877
Hirschfeld Oncology
Hirschfeld Oncology
INTERVENTIONAL
Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer
The study focuses on advanced metastatic pancreatic cancer, testing a combination of low-dose anti-cancer drugs (G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin) with the addition of Mitomycin C. The aim is to find a safer and more effective therapy for this devastating disease.
Objective: Evaluate the safety, tolerability, and efficacy of G-FLIP combined with Mitomycin C for advanced pancreatic cancer. Design: Open-label study with 60 evaluable subjects. Treatments: G-FLIP administered every 2 weeks, with Mitomycin administered every 4 weeks. Efficacy Assessments: Based on response criteria (Complete Response, Partial Response, Stable Disease, Progressive Disease), Response Rate, Progression-Free-Survival, Overall Survival, and 12-Month Survival Rate. Safety Assessments: Include physical exams, symptom evaluation, vital signs, ECOG performance status, clinical pathology, urinalysis, and Quality of Life assessments.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-01-10 | N/A | 2024-02-26 |
2024-01-22 | N/A | 2024-02-28 |
2024-01-31 | N/A | 2024-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: G-GLIP plus Mitomycin C G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin every 2 weeks plus Mitomycin C every 4 weeks | DRUG: G-GLIP plus Mitomycin C
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Survival | This measure assesses the duration of time from the start of the study until death from any cause. | Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years. |
| Response Rate | This measure assesses the rate of disease progression or worsening, as determined by changes in tumor size and appearance on radiological scans. The evaluation is conducted using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, which provide a standardized method for measuring tumor size and categorizing response to treatment." | Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Azriel Hirschfeld, MD Phone Number: 7187324050 Email: ah@honcology.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
