Adenocarcinoma of the PancreasPhase 2NCT00609336
Perioperative Therapy for Resectable Pancreatic Cancer
A Phase 2 study testing gemcitabine hydrochloride, docetaxel and capecitabine in people with Adenocarcinoma of the Pancreas and Stage IA Pancreatic Cancer, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Pancreas, Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer
- What is being tested?
- gemcitabine hydrochloride, docetaxel and capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2016
- 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
- Patients must have histologically or cytologically confirmed diagnosis of localized, resectable or borderline resectable, pancreatic adenocarcinoma T1-T3, N0-N1, M0; stage is determined by helical multi-phase computed tomography (CT) and/or endoscopic ultrasound according to published guidelines; resectability is determined by the treating surgeon and published guidelines (National Comprehensive Cancer Network)
- Resectable Disease- Head/Body/Tail of pancreas:
- No distant metastases
- Clear fat plane around celiac and superior mesenteric arteries (SMA)
- Patent superior mesenteric vein (SMV) and portal vein (PV)
- Borderline Resectable Disease -Head/Body of pancreas:
Show all 27Show fewer
- Tumor abutment on SMA
- SMV/portal vein impingement or occlusion if involving only a short segment, with open vein both proximally and distally (if proximal vein is occluded up to the portal vein branches then disease is unresectable)
- Colon or mesocolon invasion
- Gastroduodenal artery (GDA) encasement up to origin at hepatic artery
- Tail of pancreas:
- Adrenal, colon or mesocolon, or kidney invasion
- Preoperative evidence of biopsy-positive peripancreatic lymph node
- No prior therapy for pancreatic cancer
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Leucocytes >= 3,000/uL
- Absolute Neutrophil Count >= 1,500/uL
- Platelets >= 100,000/uL
- Total Bilirubin:
- If within normal limits (WNL) to =< 2.0, the subject is eligible
- If > 2.0 - < 6.0, subject is eligible IF they have a biliary stent and total bilirubin is decreasing
- If >= 6.0, subject is not eligible
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvic transaminase [SGPT]) =< 2.5 X institutional upper limit of normal or =< 1.5 X upper limit of normal (ULN) if alkaline phosphatase (Alk Phos) > 2.5 X ULN or if the subject has a biliary stent and the liver function tests (LFTs) are decreasing the subject is eligible
- Creatinine clearance >= 30%
- Negative pregnancy test for women of childbearing potential; women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to swallow and retain oral medication
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- Patients may not be receiving any other investigational agents
- Histology other than adenocarcinoma
- Patients with permanently unresectable pancreatic adenocarcinoma as determined by the treating physician and published guidelines (National Comprehensive Cancer Network)
- Unresectable disease
- Head of pancreas:
- Distant metastases (includes celiac and/or para-aortic)
Show all 25Show fewer
- SMA, celiac encasement
- SMV/portal occlusion
- Aortic, inferior vena cava (IVC) invasion or encasement
- Invasion of SMV below transverse mesocolon
- Body of pancreas:
- Distant metastases (includes celiac and/or para-aortic); at the discretion of the treating surgeon, body and tail lesions that have positive celiac and/or para-aortic nodes in close vicinity to the primary may be borderline rather than unresectable
- SMA, celiac, hepatic encasement
- SMV/portal extended occlusion
- Aortic invasion
- Tail of pancreas:
- Distant metastases (includes celiac and/or para-aortic)
- SMA, celiac encasement
- Rib, vertebral invasion
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, docetaxel, capecitabine, oxaliplatin or other agents used in the study
- Patients who have received prior chemotherapy or radiotherapy for the diagnosis of pancreatic cancer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Inability to comply with study and/or follow-up procedures
- Pregnancy or lactation
- Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Adenocarcinoma of the Pancreas, Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer
- Being tested
- gemcitabine hydrochloride, docetaxel, capecitabine, intensity-modulated radiation therapy, oxaliplatin
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Given IV
docetaxelDrug
Also called RP 56976, Taxotere, TXT
Given IV
capecitabineDrug
Also called CAPE, Ro 09-1978/000, Xeloda
Given PO
intensity-modulated radiation therapyRadiation
Also called IMRT
Undergo IMRT
oxaliplatinDrug
Also called 1-OHP, Dacotin, Dacplat, Eloxatin
Given IV
pancreatic surgical procedureProcedure or surgery
Also called pancreatic surgery
Undergo pancreaticoduodenectomy
therapeutic conventional surgeryProcedure or surgery
Undergo therapeutic conventional surgery
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (chemotherapy, radiation, pancreaticoduodenectomy) | Experimental | See Detailed Description Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Overall Survival of Patients With Adenocarcinoma of the Pancreas
Time at which Kaplan-Meier estimate of overall survival drops below 50%
Measured: 5 years
Secondary outcomes (8)
Percent of Patients Surviving at 5 Years
Kaplan-Meier estimate of overall survival at 5 years
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to 26 weeks after surgery
Surgical Completion Rate and Complication Rate
Measured: 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
Measured: Up to 26 weeks after surgery (the end of adjuvant chemotherapy)
Percent of Patients Surviving at Annual Intervals
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2014
- Study completionDec 2016
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 Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Andrew Coveler, University of Washington
- Investigators
- Andrew Coveler, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609336
- Sponsor's protocol ID
- 6511
- Other IDs
- NCI-2010-00553, 6511, P30CA015704
- Status last verified
- Jun 2017
- First submitted
- 6 Feb 2008
- Last updated
- 13 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00609336
- Acronym / sponsor ID
- 6511
- Conditions
- Adenocarcinoma of the Pancreas, Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2008
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Posted 13 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (chemotherapy, radiation, pancreaticoduodenectomy) | Experimental | 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 analysisSee Detailed Description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patients must have histologically or cytologically confirmed diagnosis of localized, resectable or borderline resectable, pancreatic adenocarcinoma T1-T3, N0-N1, M0; stage is determined by helical multi-phase computed tomography (CT) and/or endoscopic ultrasound according to published guidelines; resectability is determined by the treating surgeon and published guidelines (National Comprehensive Cancer Network)
- Resectable Disease- Head/Body/Tail of pancreas:
- Borderline Resectable Disease -Head/Body of pancreas:
- Tail of pancreas:
- No prior therapy for pancreatic cancer
Key exclusion criteria (25 listed)
- Patients may not be receiving any other investigational agents
- Histology other than adenocarcinoma
- Patients with permanently unresectable pancreatic adenocarcinoma as determined by the treating physician and published guidelines (National Comprehensive Cancer Network)
- Unresectable disease
- Head of pancreas:
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 |
|---|---|---|
| gemcitabine hydrochlorideAlso: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, GemzarGiven IV | Drug | Treatment (chemotherapy, radiation, pancreaticoduodenectomy) |
| docetaxelAlso: RP 56976, Taxotere, TXTGiven IV | Drug | Treatment (chemotherapy, radiation, pancreaticoduodenectomy) |
| capecitabineAlso: CAPE, Ro 09-1978/000, XelodaGiven PO | Drug | Treatment (chemotherapy, radiation, pancreaticoduodenectomy) |
| intensity-modulated radiation therapyAlso: IMRTUndergo IMRT | Radiation | Treatment (chemotherapy, radiation, pancreaticoduodenectomy) |
| oxaliplatinAlso: 1-OHP, Dacotin, Dacplat, EloxatinGiven IV | Drug | Treatment (chemotherapy, radiation, pancreaticoduodenectomy) |
| pancreatic surgical procedureAlso: pancreatic surgeryUndergo pancreaticoduodenectomy | Procedure or surgery | Treatment (chemotherapy, radiation, pancreaticoduodenectomy) |
| therapeutic conventional surgeryUndergo therapeutic conventional surgery | Procedure or surgery | Treatment (chemotherapy, radiation, pancreaticoduodenectomy) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (chemotherapy, radiation, pancreaticoduodenectomy) |
Primary outcome
Median Overall Survival of Patients With Adenocarcinoma of the Pancreas
Time frame: 5 years
Time at which Kaplan-Meier estimate of overall survival drops below 50%
8 secondary outcomes
Percent of Patients Surviving at 5 Years
Time frame: Up to 5 years
Median Recurrence Free Survival Following Pancreaticoduodenectomy
Time frame: 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
Time frame: Up to 7 years
Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy
Time frame: Up to 7 years
CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy
Time frame: Up to 26 weeks after surgery
Surgical Completion Rate and Complication Rate
Time frame: 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
Time frame: Up to 26 weeks after surgery (the end of adjuvant chemotherapy)
Percent of Patients Surviving at Annual Intervals
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- 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.
Andrew Coveler principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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 hydrochloride, docetaxel and capecitabine in people with Adenocarcinoma of the Pancreas and Stage IA Pancreatic Cancer, run by University of Washington 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 27 inclusion and 25 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: finished, as of the sponsor's last update on 13 Jul 2017. 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 13 Jul 2017). 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?
Median Overall Survival of Patients With Adenocarcinoma of the Pancreas (time frame: 5 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 13 Jul 2017.