N/A
N=40
Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer
Resectable Pancreatic Cancers
Bottom Line
View on ClinicalTrials.gov: NCT02318095 ↗Enrolled (actual)
40
Serious AEs
7.5%
Results posted
Jul 2021
Primary outcome: Primary: Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen — 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gemcitabine/nab-Paclitaxel (Drug); Radiation therapy (Radiation); Sugical resection (Other); Adjuvant chemotheapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen |
39 | — |
| SECONDARY Number of Participants Experiencing Grade >/=2 Acute Toxicity |
10 | — |
| SECONDARY Number of Participants Who Underwent Surgical Resection |
24 | — |
| SECONDARY Number of Participants Who Received an R0 Resection |
18 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT02318095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.