NCT01240304

A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemo With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas

A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemotherapy With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase II clinical trial study is to assess the resection rate among subjects who have been initially diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma. This will be done by providing preoperative treatment that will include alternating cycles of chemotherapy and radiotherapy treatment. In addition, this clinical trial will assess the safety of preoperative chemotherapy with radiation therapy for subjects with unresectable or borderline resectable adenocarcinoma of the pancreatic head, assess margin-negative resection rates, disease-free survival, assess overall survival rates, and determine patterns of local and distant recurrence.

Detailed description

The purpose of this phase II clinical trial study is to assess the resection rate among subjects who have been initially diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma. This will be done by providing preoperative treatment that will include alternating cycles of chemotherapy and radiotherapy treatment. In addition, this clinical trial will assess the safety of preoperative chemotherapy with radiation therapy for subjects with unresectable or borderline resectable adenocarcinoma of the pancreatic head, assess margin-negative resection rates, disease-free survival, assess overall survival rates, and determine patterns of local and distant recurrence. The study population in this clinical trial will consist of untreated subjects 18 years or older who have a histologically or cytologically confirmed diagnosis of unresectable or borderline resectable adenocarcinoma of the pancreatic head. Once the patient has undergone the necessary tests and the tumor has been staged, the principal investigator or co-investigators will determine if the patient is suitable to be inducted in this clinical trial. The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemzar for 24 hours and 7.0 Gy of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles of 1000mg/M² of Gemzar over a 30 minute infusion rate. The primary outcome of this clinical trial is the margin-negative resection rate. This will be determined by the tumor's response to the pre/post-operative treatment so that the tumor can be removed surgically via pancreaticoduodenectomy. Once the subject has completed the treatment as described in the protocol, he/she will continued to be followed to assess survival and patterns of local and distance recurrence. The purpose of this clinical trial will be an attempt to provide subjects with a more hopeful alternative to treatment for a disease that otherwise offers a grim prognosis.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate.
RADIATION	Radiation therapy	The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate.
PROCEDURE	pancreaticoduodenectomy	Surgery will be planned 28 days (+/- 3 days) after the last dose of chemotherapy. The liver and pancreas will be examined by palpation and inspection. In the absence of metastases, tumor mobilization and surgical resection will be performed with standard surgical technique.

Timeline

• Start date: 2010-11-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2010-11-15
• Last updated: 2019-12-10
• Results posted: 2019-12-10

Locations

1 site across 1 country: United States