Adjuvant Chemotherapy for Pancreatic Cancer
Trial Summary
What is the purpose of this trial?
Primary Objectives: To determine the disease free survival (DFS) for participants treated with post-operative adjuvant chemotherapy, as compared to neoadjuvant therapy alone. Secondary Objectives: To determine the clinical efficacy of the study treatment in terms of median overall survival (OS) and median disease free survival (DFS). To assess the safety and tolerability of the study treatment regimen as measured by the adverse events rates. To assess the quality of life in patients receiving the study treatment.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any investigational agents at the time of registration.
What data supports the idea that Adjuvant Chemotherapy for Pancreatic Cancer (also known as: Capecitabine, Xeloda, Gemcitabine, Gemzar) is an effective treatment?
The available research shows that using a combination of the drugs gemcitabine and capecitabine (GEMCAP) is more effective than using gemcitabine alone for treating pancreatic cancer. In a study, patients who received GEMCAP lived longer, with a median survival of 31.4 months compared to 22.1 months for those who only received gemcitabine. This suggests that GEMCAP is a more effective treatment option for pancreatic cancer.12345
What safety data exists for adjuvant chemotherapy in pancreatic cancer?
Safety data for adjuvant chemotherapy in pancreatic cancer includes studies on capecitabine (Xeloda) and gemcitabine (Gemzar). Capecitabine has been evaluated for safety in patients with advanced pancreatic cancer. Gemcitabine, alone and in combination with capecitabine, has been studied in various trials, showing potential benefits but also side effects like myelotoxicity, nausea, and vomiting. The combination of gemcitabine and capecitabine (GemCap) has been shown to improve overall survival compared to gemcitabine alone, with safety evaluations conducted in different populations.36789
Is the drug used in the trial 'Adjuvant Chemotherapy for Pancreatic Cancer' a promising treatment?
Research Team
Prateek Gulhati, MD
Principal Investigator
Rutgers Cancer Institute of New Jersey
Eligibility Criteria
This trial is for adults with pancreatic cancer who've had neoadjuvant chemotherapy and surgery to remove the tumor. They should be in fair to good physical condition, have normal blood counts and organ function, and agree to use birth control. People can't join if they're pregnant, have severe liver problems, other active cancers or major illnesses that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Capecitabine
- Gemcitabine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor