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2008-01
2014-11
2016-12
35
NCT00609336
University of Washington
University of Washington
INTERVENTIONAL
Perioperative Therapy for Resectable Pancreatic Cancer
This phase II trial studies how well giving combination chemotherapy together with intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with localized pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with intensity-modulated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PRIMARY OBJECTIVES: I. To estimate the median overall survival of patients with adenocarcinoma of the pancreas treated with induction chemotherapy, neoadjuvant chemoradiotherapy, surgical resection and adjuvant chemotherapy. SECONDARY OBJECTIVES: I. To determine the percent of patients surviving at annual intervals through five years. II. To determine the median recurrence free survival following pancreaticoduodenectomy. III. To determine the clinical response rate to neoadjuvant chemotherapy and chemoradiotherapy. IV. To determine the pathologic response rate to neoadjuvant chemotherapy and chemoradiotherapy. V. To determine the cancer antigen (CA) 19-9 tumor marker response rate to neoadjuvant chemotherapy and chemoradiotherapy. VI. To determine the surgical completion rate and complication rate following neoadjuvant chemotherapy and chemoradiotherapy. VII. To determine the frequency and severity of toxicities associated with this treatment regimen. OUTLINE: INDUCTION CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV) over 75 minutes and docetaxel IV over 30 or 60 minutes on days 4 and 11. Patients also receive capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. NEOADJUVANT CHEMORADIOTHERAPY: Beginning no more than 14 days after completion of induction chemotherapy, patients receive capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Patients also undergo IMRT once daily on days 1-5 and 8-13. SURGICAL RESECTION: Approximately 2-6 weeks after completion of neoadjuvant chemoradiotherapy, patients undergo pancreaticoduodenectomy. ADJUVANT CHEMOTHERAPY: Beginning 4-10 weeks after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.
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 |
|---|---|---|
2008-02-06 | 2017-03-21 | 2017-06-13 |
2008-02-06 | 2017-06-13 | 2017-07-13 |
2008-02-07 | 2017-07-13 | 2017-06 |
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: Treatment (chemotherapy, radiation, pancreaticoduodenectomy) See Detailed Description | DRUG: gemcitabine hydrochloride
DRUG: docetaxel
DRUG: capecitabine
RADIATION: intensity-modulated radiation therapy
DRUG: oxaliplatin
PROCEDURE: pancreatic surgical procedure
PROCEDURE: therapeutic conventional surgery
OTHER: laboratory biomarker analysis
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Median Overall Survival of Patients With Adenocarcinoma of the Pancreas | Time at which Kaplan-Meier estimate of overall survival drops below 50% | 5 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Percent of Patients Surviving at 5 Years | Kaplan-Meier estimate of overall survival at 5 years | Up to 5 years |
| Median Recurrence Free Survival Following Pancreaticoduodenectomy | The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence. | From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years |
| Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy | Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. | Up to 7 years |
| Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy | The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM). Cancer 2012;118:1382-90 | Up to 7 years |
| CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy | Biochemical response is a decrease of >= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline. | Up to 26 weeks after surgery |
| Surgical Completion Rate and Complication Rate | Up to 6 weeks following the completion of chemoradiotherapy | |
| Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Up to 26 weeks after surgery (the end of adjuvant chemotherapy) | |
| Percent of Patients Surviving at Annual Intervals | 5 years |
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
No publications available
