Resectable Pancreatic CancersNCT02318095
Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer
A study testing Gemcitabine/nab-Paclitaxel, Radiation therapy and Sugical resection in people with Resectable Pancreatic Cancers, run by Duke University at 1 site in United States.
Trial summary
This research protocol will evaluate the feasibility of administering neoadjuvant gemcitabine and nab-paclitaxel with hypofractionated, image guided, intensity modulated radiotherapy (HIGRT) in resectable and borderline resectable pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Cancers
- What is being tested?
- Gemcitabine/nab-Paclitaxel, Radiation therapy and Sugical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2015to 14 Nov 2022
- Phase
- Interventional
- 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
- Patient has signed informed consent and is willing to comply with the protocol
- Histologically or cytologically proven adenocarcinoma of the pancreas (within the last 90 days)
- Either resectable or borderline resectable as determined on staging imaging (as defined by National Comprehensive Cancer Network [NCCN])
- Patient is 18 years or older
- Karnofsky performance status 70 or greater
- The ANC count ≥ 1500, the platelet count ≥ 100,000 and hemoglobin ≥ 9g/dL
- Laboratory values meet the following constraints: Bilirubin less than or equal to 2 mg/dL; AST and ALT less than or equal to 3 x ULN (stenting to improve biliary obstruction is permitted)
- No evidence of metastatic disease based on imaging of the chest, abdomen and pelvis.
Who cannot join
- Metastatic disease on pretreatment imaging
- Prior systemic therapy
- Prior abdominal radiation. Any prior radiation must be approved by the Radiation Oncology PI
- Previous treatment for pancreatic cancer
- Patients with any serious/poorly controlled medical or psychological conditions that would be exacerbated by treatment, would complicate protocol compliance
- Pregnant or lactating. Adequate birth control must be used if of child bearing potential per institutional policy. Negative pregnancy test in female patients of child-bearing potential per institutional policy. Post-menopausal women must have had amenorrhea for at least 18 months to be considered non-child bearing
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- Clinically significant peripheral vascular disease
- Presence of active or chronic infection
- Clinically significant atherosclerotic cardiovascular disease including patients with New York Heart Class II/III/IV CHF, ventricular arrhythmias requiring medication, myocardial infarction, cerebrovascular accident, transient ischemic attack, coronary artery bypass grafting, angioplasty, cardiac or other vascular stenting within the past 6 months
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within six months prior to treatment start
- History of collagen vascular disease or inflammatory bowel disease (Crohn's or ulcerative colitis)
- Current grade 2 or higher peripheral neuropathy
- Anticoagulation with warfarin
- History of arterial thromboembolic events or symptomatic pulmonary embolism within the past 6 months
- Active bleeding diathesis or history of major bleeding, CNS bleeding, or significant hemoptysis within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Neoadjuvant Gemcitabine/Nab-Paclitaxel and Hypofractionated Image-Guided Intensity Modulated Radiotherapy in Resectable and Borderline Resectable Pancreatic Cancer
This research protocol will evaluate the feasibility of administering neoadjuvant gemcitabine and nab-paclitaxel with hypofractionated, image guided, intensity modulated radiotherapy (HIGRT) in resectable and borderline resectable pancreatic cancer
Read the detailed description
Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and accounts for roughly 40,000 deaths each year. Despite the use of neoadjuvant and adjuvant therapies, little progress has been made in the the last three decades, and the search for more efficacious treatment continues.In patients with a good performance status the combination of effective systemic therapy with gemcitabine/nab-paclitaxel and high dose local radiotherapy may improve disease outcomes. This is a prospective, single arm study in patients in newly diagnosed, previously untreated pancreatic cancer who are planned to undergo surgical resection The primary objective of this study is to evaluate the toxicity of a neoadjuvant approach incorporating gemcitabine/nab-paclitaxel and Hypofractionated image guided intensity-modulated radiotherapy (HIGRT) prior to surgical resection. Eligible subjects will recieve standard neoadjuvant gemcitabine and nab-paclitaxel dosing is as follows:Nab-Paclitaxel (125mg/m2) days 1,8,15 every 28 days for 2 cycles Gemcitabine (1000mg/m2) days 1,8,15 every 28 days for 2 cycles followed by HIGRT and surgical resection.
Adjuvant chemotherapy may be given post surgery at the discretion of the treating medical oncologist.
- Conditions
- Resectable Pancreatic Cancers
- Being tested
- Gemcitabine/nab-Paclitaxel, Radiation therapy, Sugical resection, Adjuvant chemotheapy
- Keywords
- Cancer of the pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine/nab-PaclitaxelDrug
Prospective, single arm study ; eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel. All chemotherapy administered to study subjects is standard of care. The chemotherapy combination, gemcitabine/nab-paclitaxel, is considered to be a standard-of-care, non-investigational chemotherapy combination; chemotherapy dosing and treatment schedule will be managed by the treating medical oncologist. Restaging will be completed post chemotherapy.
Radiation therapyRadiation
5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.
Sugical resectionOther
Surgical resection of the pancreas post radiation therapy
Adjuvant chemotheapyDrug
Adjuvant chemotherapy may be given after surgery at the clinical discretion of the medical oncologist
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy/radiation/surgery | Other | This is a single arm prospective study. All eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist. Receives: Drug: Gemcitabine/nab-Paclitaxel; Radiation: Radiation therapy; Other: Sugical resection; Drug: Adjuvant chemotheapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen
The neoadjuvant regimen will be considered feasible if (a) the trial can accrue 25 patients in no more than 3 years and (b) if at least 17 of the 25 patients adhere to the neoadjuvant regimen and c) the acute grade 3+ non-hematologic acute toxicity is less than 50% (exclusing fatigue and alopecia).
Measured: approximately 6 months
Secondary outcomes (3)
Number of Participants Experiencing Grade >/=2 Acute Toxicity
CTCAE version 4 will be used for all toxicity assessments. The acute toxicity rate, defined as any non-hematologic grade 2+ toxicity occurring during HIGRT treatment through 60 days post-treatment, will be estimated with its exact 80% confidence interval. Likewise, we will determine the rate of grade 2+ hematologic toxicity occurring during treatment through 60 days post treatment and the proportion of patients requiring treatment breaks longer than 5 days.
Measured: 60 days post surgery
Number of Participants Who Underwent Surgical Resection
Patients who undergo surgical resection will be documented
Measured: 14-30 days post surgery
Number of Participants Who Received an R0 Resection
Pathologic review will determine if an R0 resection has been performed. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Measured: 14-30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study start17 Feb 2015
- Primary completion7 Nov 2018
- Study completion14 Nov 2022
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 Resectable Pancreatic CancersStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manisha Palta, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318095
- Sponsor's protocol ID
- Pro00058865
- Status last verified
- Oct 2023
- First submitted
- 12 Dec 2014
- Last updated
- 26 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Neoadjuvant Gemcitabine/Nab-Paclitaxel and Hypofractionated Image-Guided Intensity Modulated Radiotherapy in Resectable and Borderline Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02318095
- Acronym / sponsor ID
- Pro00058865
- Conditions
- Resectable Pancreatic Cancers
- Keywords
- Cancer of the pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 Feb 2015 (actual)
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Posted 1 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research protocol will evaluate the feasibility of administering neoadjuvant gemcitabine and nab-paclitaxel with hypofractionated, image guided, intensity modulated radiotherapy (HIGRT) in resectable and borderline resectable pancreatic cancer
Detailed description
Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and accounts for roughly 40,000 deaths each year. Despite the use of neoadjuvant and adjuvant therapies, little progress has been made in the the last three decades, and the search for more efficacious treatment continues.In patients with a good performance status the combination of effective systemic therapy with gemcitabine/nab-paclitaxel and high dose local radiotherapy may improve disease outcomes. This is a prospective, single arm study in patients in newly diagnosed, previously untreated pancreatic cancer who are planned to undergo surgical resection The primary objective of this study is to evaluate the toxicity of a neoadjuvant approach incorporating gemcitabine/nab-paclitaxel and Hypofractionated image guided intensity-modulated radiotherapy (HIGRT) prior to surgical resection. Eligible subjects will recieve standard neoadjuvant gemcitabine and nab-paclitaxel dosing is as follows:Nab-Paclitaxel (125mg/m2) days 1,8,15 every 28 days for 2 cycles Gemcitabine (1000mg/m2) days 1,8,15 every 28 days for 2 cycles followed by HIGRT and surgical resection.
Adjuvant chemotherapy may be given post surgery at the discretion of the treating medical oncologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy/radiation/surgery | Other | Drug: Gemcitabine/nab-Paclitaxel, Radiation: Radiation therapy, Other: Sugical resection, Drug: Adjuvant chemotheapyThis is a single arm prospective study. All eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has signed informed consent and is willing to comply with the protocol
- Histologically or cytologically proven adenocarcinoma of the pancreas (within the last 90 days)
- Either resectable or borderline resectable as determined on staging imaging (as defined by National Comprehensive Cancer Network [NCCN])
- Patient is 18 years or older
- Karnofsky performance status 70 or greater
Key exclusion criteria (15 listed)
- Metastatic disease on pretreatment imaging
- Prior systemic therapy
- Prior abdominal radiation. Any prior radiation must be approved by the Radiation Oncology PI
- Previous treatment for pancreatic cancer
- Patients with any serious/poorly controlled medical or psychological conditions that would be exacerbated by treatment, would complicate protocol compliance
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/nab-PaclitaxelProspective, single arm study ; eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel. All chemotherapy administered to study subjects is standard of care. The chemotherapy combination, gemcitabine/nab-paclitaxel, is considered to be a standard-of-care, non-investigational chemotherapy combination; chemotherapy dosing and treatment schedule will be managed by the treating medical oncologist. Restaging will be completed post chemotherapy. | Drug | Chemotherapy/radiation/surgery |
| Radiation therapy5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy. | Radiation | Chemotherapy/radiation/surgery |
| Sugical resectionSurgical resection of the pancreas post radiation therapy | Other | Chemotherapy/radiation/surgery |
| Adjuvant chemotheapyAdjuvant chemotherapy may be given after surgery at the clinical discretion of the medical oncologist | Drug | Chemotherapy/radiation/surgery |
Primary outcome
Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen
Time frame: approximately 6 months
The neoadjuvant regimen will be considered feasible if (a) the trial can accrue 25 patients in no more than 3 years and (b) if at least 17 of the 25 patients adhere to the neoadjuvant regimen and c) the acute grade 3+ non-hematologic acute toxicity is less than 50% (exclusing fatigue and alopecia).
3 secondary outcomes
Number of Participants Experiencing Grade >/=2 Acute Toxicity
Time frame: 60 days post surgery
Number of Participants Who Underwent Surgical Resection
Time frame: 14-30 days post surgery
Number of Participants Who Received an R0 Resection
Time frame: 14-30 days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- 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.
Manisha Palta, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gemcitabine/nab-Paclitaxel, Radiation therapy and Sugical resection in people with Resectable Pancreatic Cancers, run by Duke University 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 8 inclusion and 15 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 26 Oct 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2021). 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?
Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen (time frame: approximately 6 months). 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 26 Oct 2023.