Back to resultsA Phase II Study to Assess the Efficacy and Safety of Preoperative Chemo With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Radiation therapy
pancreaticoduodenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Ages 18 years and above. There will be no upper age restriction.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. (See Appendix A -ECOG Performance Status Scale).
- Cytologic or histologic proof of adenocarcinoma of pancreas.
Adequate renal, and bone marrow function:
- Leukocytes >= 3,000/uL (upper limit)
- Absolute neutrophil count >= 1,500/uL (upper limit)
- Platelets >= 100,000/Ul
- Serum creatinine <= 2.0 mg/dL
Hepatic function (endoscopic or percutaneous drainage as needed)
a. Aspartate aminotransferase (AST)-(SGOT)/Alanine aminotransferase (ALT) (SGPT) <= 5 X institutional ULN (upper limit of normal)
Borderline resectable pancreatic cancer:
- Short segment hepatic artery abutment (< 180° involvement)
- Tumor abutment (<180° ) of superior mesenteric artery
- Superior mesenteric/portal vein involvement beyond that of a simple resection and reconstruction
- Pancreatitis that obscures the determination of vessel involvement and may preclude an otherwise curative operation
Unresectable pancreatic cancer:
- Tumors that encase (> 180° involvement) single or multiple arteries and veins (celiac axis, superior mesenteric artery, superior mesenteric/portal vein, hepatic artery)
- Occlusion of superior mesenteric/portal vein
Exclusion Criteria:
- Infections such as cholangitis, pneumonia, or wound infections that would preclude protocol therapy.
- Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
- Subjects cannot have known heptic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy/laparoscopy prior to treatment.
- Subjects with unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure will be excluded (see Appendix B).
- Known presence of central nervous system or brain metastases
- Subjects with prior radiotherapy to the upper abdomen or liver will be excluded.
- Subjects will be excluded if deemed unable to comply with study and/or follow-up procedures.
- Subjects with a known hypersensitivity to Gemzar are excluded.
- Multiple positive lymph nodes, which will make the radiotherapy treatment volume too large. Peripancreatic involved nodes can be included in the radiotherapy treatment volume if the field of involved nodes is less than 7.5cm.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemcitabine, radiation therapy, surgery
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01240304
First Posted
November 9, 2010
Last Updated
November 21, 2019
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT01240304
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
no subjects enrolled
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine, radiation therapy, surgery
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
pancreaticoduodenectomy
Other Intervention Name(s)
Removal of pancreas
Intervention Description
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.
Primary Outcome Measure Information:
Title
Margin-negative Resection Rate
Description
This will be determined by the tumor's response to the pre/post-operative treatment so that the tumor can be removed surgically.
Time Frame
An average of 6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 18 years and above. There will be no upper age restriction.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. (See Appendix A -ECOG Performance Status Scale).
Cytologic or histologic proof of adenocarcinoma of pancreas.
Adequate renal, and bone marrow function:
Leukocytes >= 3,000/uL (upper limit)
Absolute neutrophil count >= 1,500/uL (upper limit)
Platelets >= 100,000/Ul
Serum creatinine <= 2.0 mg/dL
Hepatic function (endoscopic or percutaneous drainage as needed)
a. Aspartate aminotransferase (AST)-(SGOT)/Alanine aminotransferase (ALT) (SGPT) <= 5 X institutional ULN (upper limit of normal)
Borderline resectable pancreatic cancer:
Short segment hepatic artery abutment (< 180° involvement)
Tumor abutment (<180° ) of superior mesenteric artery
Superior mesenteric/portal vein involvement beyond that of a simple resection and reconstruction
Pancreatitis that obscures the determination of vessel involvement and may preclude an otherwise curative operation
Unresectable pancreatic cancer:
Tumors that encase (> 180° involvement) single or multiple arteries and veins (celiac axis, superior mesenteric artery, superior mesenteric/portal vein, hepatic artery)
Occlusion of superior mesenteric/portal vein
Exclusion Criteria:
Infections such as cholangitis, pneumonia, or wound infections that would preclude protocol therapy.
Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
Subjects cannot have known heptic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy/laparoscopy prior to treatment.
Subjects with unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure will be excluded (see Appendix B).
Known presence of central nervous system or brain metastases
Subjects with prior radiotherapy to the upper abdomen or liver will be excluded.
Subjects will be excluded if deemed unable to comply with study and/or follow-up procedures.
Subjects with a known hypersensitivity to Gemzar are excluded.
Multiple positive lymph nodes, which will make the radiotherapy treatment volume too large. Peripancreatic involved nodes can be included in the radiotherapy treatment volume if the field of involved nodes is less than 7.5cm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Issam Makhoul, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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