Pancreatic CancerPhase 2NCT01240304
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 2 study testing Gemcitabine, Radiation therapy and pancreaticoduodenectomy in people with Pancreatic Cancer, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine, Radiation therapy and pancreaticoduodenectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Platelets >= 100,000/Ul
- Serum creatinine <= 2.0 mg/dL
- Hepatic function (endoscopic or percutaneous drainage as needed)
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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
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.
Read the 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
- Being tested
- Gemcitabine, Radiation therapy, pancreaticoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
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 therapyRadiation
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.
pancreaticoduodenectomyProcedure or surgery
Also called Removal of pancreas
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.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, radiation therapy, surgery | Experimental | Not described Receives: Drug: Gemcitabine; Radiation: Radiation therapy; Procedure: pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: An average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2019
- Study completionOct 2019
Why it stopped: no subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Issam Makhoul, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240304
- Sponsor's protocol ID
- 112748
- Status last verified
- Nov 2019
- First submitted
- 9 Nov 2010
- Last updated
- 10 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01240304
- Acronym / sponsor ID
- 112748
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no subjects enrolled
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Posted 10 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, radiation therapy, surgery | Experimental | Drug: Gemcitabine, Radiation: Radiation therapy, Procedure: pancreaticoduodenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- Hepatic function (endoscopic or percutaneous drainage as needed)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineAlso: GemzarThe 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. | Drug | Gemcitabine, radiation therapy, surgery |
| Radiation therapyThe 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 | Gemcitabine, radiation therapy, surgery |
| pancreaticoduodenectomyAlso: Removal of pancreasSurgery 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. | Procedure or surgery | Gemcitabine, radiation therapy, surgery |
Primary outcome
Margin-negative Resection Rate
Time frame: An average of 6 years
This will be determined by the tumor's response to the pre/post-operative treatment so that the tumor can be removed surgically.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issam Makhoul, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Radiation therapy and pancreaticoduodenectomy in people with Pancreatic Cancer, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Margin-negative Resection Rate (time frame: An average of 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.