2011-11
2018-06
2022-04-11
229
NCT01726582
Medical College of Wisconsin
Medical College of Wisconsin
INTERVENTIONAL
Pancreas Cancer: Molecular Profiling as a Guide to Therapy Before and After Surgery ("Personalized Medicine")
In this clinical trial, if the doctor knows or suspects that a growth in the pancreas is cancer (adenocarcinoma), then a sample of the growth is tested (the test is called molecular profiling). The results of the test are used by the doctor to recommend therapy (chemotherapy and radiation therapy) that the patient will receive before having surgery to remove the adenocarcinoma. When the patient goes to surgery, the adenocarcinoma that is removed is tested again. The results of that test are used to guide the choice of therapy after surgery. The chemotherapy drugs and the radiation therapy used in this clinical trial are already approved for treatment of pancreas cancer. This trial is intended to establish which treatment is best for a specific patient, based on test results from that patient's actual adenocarcinoma. In the past, the decision as to which treatment the patient will receive was not based on testing of the actual adenocarcinoma. See treatment pathways at http://www.mcw.edu/surgery/patientinfo/Pancreatic-Cancer-Trial.htm. Hypothesis: Resectability rate, overall survival rate and progression-free survival in subjects with adenocarcinoma of the pancreas will be superior for who receive targeted "personalized" therapy.
N/A
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 |
|---|---|---|
2011-12-28 | 2023-05-22 | 2023-07-20 |
2012-11-09 | 2023-07-20 | 2023-08-14 |
2012-11-15 | 2023-08-14 | 2023-07 |
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: Milestones related to therapy Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging. Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT | DRUG: Milestone 1: Targeted chemotherapy prior to surgery
RADIATION: Milestone 2: Chemoradiotherapy (cXRT)
DRUG: Milestone 3: Targeted chemotherapy prior to surgery
RADIATION: Milestone 3: Chemoradiotherapy (cXRT)
DRUG: Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery
RADIATION: Milestone 4: Chemoradiotherapy (cXRT)
DRUG: Milestone 5: Targeted chemotherapy after surgery
RADIATION: Milestone 5: Chemoradiotherapy (cXRT)
DRUG: Milestone 6: Gemcitabine after surgery
RADIATION: Milestone 6: Chemoradiotherapy (cXRT)
RADIATION: Milestone 7: Chemoradiotherapy (cXRT)
DRUG: Milestone 8: Targeted chemotherapy after surgery
DRUG: Milestone 9: Gemcitabine after surgery
OTHER: Milestone 10: No additional therapy after surgery
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Subjects Completing Therapy Including Surgical Resection. | This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure. | At time of surgery (approximately 10 to 20 weeks after screening) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Survival in Months | This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection. | 5 years |
| Progression-free Survival | This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy. | 5 years |
| Use of Biomarkers to Determine Course of Treatment | The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment. | Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening) |
| Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors. | The number of tumors showing a histologic response. Histological response will be measured using the Ryan Score method as defined by the American Joint Committee on Cancer, 7th edition (see Edge, 2010). Grading categories are defined as: Grade 0 (complete response); Grade 1 (near complete response); Grade 2 (partial response); and Grade 3 (poor or no response). | At time of surgery (approximately 10 to 20 weeks after screening) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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