Post-Chemotherapy Surgery for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if surgery after chemotherapy can safely remove tumors in individuals with pancreatic cancer that has spread to nearby areas but not to distant organs. The focus is on those who have received chemotherapy to shrink the tumor but still cannot undergo surgery because the cancer is too close to vital blood vessels or tissues. Patients with pancreatic cancer that hasn't spread far and who have completed at least four cycles of chemotherapy without disease progression might be suitable candidates. As an unphased trial, this study provides patients the chance to contribute to significant research that could lead to new treatment options for pancreatic cancer.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.
What prior data suggests that this surgical procedure is safe for treating pancreatic cancer?
Research has shown that removing the pancreas through a surgery called total pancreatectomy carries significant risks. Studies indicate that complications, or health problems after the surgery, occur in 36.2% to 75% of patients. The risk of death from the surgery, known as mortality, ranges from 4% to 26.9%. While the surgery can save lives, it also presents serious risks.
One study found that total pancreatectomy is riskier than a similar surgery called pancreatoduodenectomy. Patients undergoing total pancreatectomy may face more issues during and after the procedure.
These findings underscore the surgery's complexity. Patients should discuss these risks with their doctors to understand how they might affect them personally.12345Why are researchers excited about this trial?
Unlike the standard treatments for pancreatic cancer, which often involve chemotherapy or localized surgical procedures, total pancreatectomy offers a more comprehensive surgical approach. This technique involves the removal of the entire pancreas, potentially providing a more thorough elimination of cancerous tissue. Researchers are excited about this because, combined with neoadjuvant chemotherapy, it might improve the overall outcomes for patients by reducing the risk of recurrence. Additionally, the integration of advanced imaging and tissue collection during the procedure allows for better monitoring and understanding of the disease, paving the way for more personalized treatment strategies in the future.
What evidence suggests that surgery after neoadjuvant chemotherapy could be effective for treating locally advanced pancreatic cancer?
Research has shown that surgery following chemotherapy can improve outcomes for people with pancreatic cancer. In this trial, participants will undergo one of several surgical procedures, including the Whipple procedure (pancreaticoduodenectomy), distal pancreatectomy, or total pancreatectomy, based on the surgeon's discretion. The Whipple procedure offers a 5-year survival rate of about 29% for these patients. Distal pancreatectomy can result in a median survival time of up to 88.8 months for tumors in the pancreatic tail. Although riskier, total pancreatectomy has also demonstrated better survival rates, with studies reporting a 5-year survival rate of around 29%. These surgical options, especially when performed after chemotherapy, offer hope by potentially increasing survival and managing cancer that initially seems untreatable.678910
Who Is on the Research Team?
Steven R Grossman, MD
Principal Investigator
University of Southern California
Are You a Good Fit for This Trial?
Adults with pancreatic adenocarcinoma that's locally advanced and can't be surgically removed. They must have completed at least 4 cycles of specific chemotherapy without the cancer getting worse, have a good performance status, and agree to use contraception. Not for those who've had certain prior treatments or uncontrolled illnesses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Participants receive standard of care neoadjuvant chemotherapy regimen
Surgical Resection
Participants undergo laparoscopy followed by surgical resection with pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Biospecimen Collection
- Distal Pancreatectomy
- Laparoscopy
- Magnetic Resonance Imaging
- Pancreaticoduodenectomy
- Surgical Procedure
- Total Pancreatectomy
Trial Overview
The trial is testing if surgery after neoadjuvant chemotherapy (chemo before surgery) can safely remove tumors in patients whose pancreatic cancer has spread nearby but isn't removable by initial surgery.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Patients undergo laparoscopy followed by surgical resection with pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy at the discretion of the surgeon within 2-8 weeks following completion of standard of care neoadjuvant chemotherapy regimen. Patients undergo CT and blood sample collection throughout the study and/or MRI during screening. Patients also undergo tissue collection at time of surgical resection on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Survival Outcomes of Adjuvant Chemotherapy Combined ...
In the group of patients who received adjuvant therapy (63/87), they noted a median survival of 39 months and a 5-year survival 33.9%, which is similar to our ...
Outcomes Clinical efficacy of pancreas-preserving distal ...
The median survival duration of patients who underwent pancreas-preserving DP for the treatment of pancreatic tail tumors was 88.8 months, and that of patients ...
Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as ...
In patients receiving chemotherapy with modified FOLFIRINOX vs gemcitabine, median disease-free survival was 21.4 months (95% CI, 17.5-26.7) vs ...
4.
cancer.gov
cancer.gov/news-events/cancer-currents-blog/2018/pancreatic-cancer-chemotherapy-regimen-changeChemotherapy Change Improves Pancreatic Cancer ...
The results showed that people with early-stage pancreatic cancer treated with chemotherapy and radiation therapy before surgery lived about 1.5 months longer.
Extended Distal Pancreatectomy for Cancer of the Body ...
In our experience, 95% of the patients who underwent resection for distal pancreatic adenocarcinoma presented tumor recurrence, with a median disease-free ...
Total pancreatectomy compared with ...
In studies focusing on pancreatic cancer, the morbidity of TP ranged from 36.2% to 75.0% and mortality ranged from 4.0% to 26.9%. 3-OS ranged from 4.5% to 36.6% ...
Perioperative and oncologic outcomes after total ...
The results of this study show greater perioperative morbidity and mortality after total pancreatectomy compared with pancreatoduodenectomy for pancreatic head ...
Effects of Total Pancreatectomy on Survival of Patients With ...
We developed a practical nomogram to predict the prognosis of PDAC patients treated with TP, which showed superiority over the conventional AJCC staging system.
Short- and Long-Term Outcomes after Pancreatectomy for ...
In contrast, long-term outcomes were poor, with a median overall survival of just 8.4 months after pancreatectomy; notably, none of the patients ...
Contemporary report of surgical outcomes after single ...
Median survival for the entire cohort was 24.4 months; 22.7 months for PDAC patients, with 1-, 3-, and 5-year survival of 68%, 43%, and 16%, ...
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