Chemoradiation in Locally Advanced Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Interferon alfa may interfere with the growth of tumor cells. Giving combination chemotherapy and radiation therapy together with interferon alfa before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy and radiation therapy together with interferon alfa works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
Biological: recombinant interferon alfa
Radiation: radiation therapy
Procedure: Resection of tumor
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Pilot Study of Multi-Agent Neo-Adjuvant Chemoradiation in Patients With Locally Advanced Pancreatic Adenocarcinoma|
- Number of Patients in Whom Tumor Was Resectable [ Time Frame: Up to 5 Years or Until Disease Progression ] [ Designated as safety issue: No ]Tumor response is measured in terms of resectability, as measured by CT scan at 2 weeks after completion of each course. A CT scan of the chest abdomen and pelvis will be performed in order to evaluate for the presence of metastatic disease. If no metastatic disease, emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. If potential for resection then surgery will be recommended. This protocol will be followed after each cycle.
- Overall Survival [ Time Frame: Up to 5 Years or Date of Death, Whichever Occurred First ] [ Designated as safety issue: No ]In all patients, measured from the date of the patient's registration in this study, until the date of the patient's death or date last known alive (if observation was censored).
|Study Start Date:||January 2005|
|Study Completion Date:||August 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Pancreatic Adenocarcinoma Patients
Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery).
Biological: recombinant interferon alfa
administered subcutaneously (SQ)at a dose of 3 million units Day 1,3, and 5 each week in Cycle 1
Other Names:Drug: cisplatin
administered at a dose of 30 mg/m2 intravenously (IV) day 1 each week in Cycle 1
Other Names:Drug: fluorouracil
administered at a dose of 175 mg/m^2/day continuous infusion (CI) for 38 days in Cycle 1 and then 500 mg/m^2 intravenously (IV) each week for 6 weeks followed by a 2 week rest (1 cycle = 8 weeks)in Cycle 2 and 3
Other Name: 5-FURadiation: radiation therapy
5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks (days 1-5, 8-12, 15-19, 22-26, 29-33, 36-38).Procedure: Resection of tumor
After Cycle 1 treatment (if resectable)- In the absence of metastatic disease, special emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. Surgical exploration will start with a diagnostic laparoscopy. If no evidence of carcinomatosis, liver metastases or other evidence of metastatic disease is encountered, then a laparotomy will be performed. In the absence of clear technical unresectability, a radical pancreaticoduodenectomy, distal or total pancreatectomy (and resection of any involved structures) will be performed as mandated by tumor anatomy.
- Determine the effect of neoadjuvant chemoradiotherapy and interferon alfa on converting patients with locally advanced unresectable adenocarcinoma of the pancreas to resectability.
- Determine the rate and severity of early and late toxic effects of these regimens in these patients.
- Improve surgical morbidity profile and overall survival of patients who undergo surgical resection.
- Determine overall and progression-free survival of patients treated with this regimen.
OUTLINE: This is an pilot, single center study.
- Part 1 (neoadjuvant therapy): Patients receive fluorouracil IV continuously over 24 hours on days 1-38; cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, and 38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients then undergo restaging. Patients with resectable disease undergo surgery, and 4-10 weeks later, proceed to part 2. Patients with unresectable disease proceed directly to part 2, 4 weeks after completion of neoadjuvant therapy.
- Part 2 (chemotherapy): Patients receive fluorouracil IV on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with unresectable disease undergo restaging after each course of fluorouracil. If the tumor subsequently becomes resectable, patients then undergo surgery.
After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262951
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Study Chair:||Edward W. Greeno, MD||Masonic Cancer Center, University of Minnesota|