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N/A Completed N=40 Treatment

Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer

Source: ClinicalTrials.gov NCT02318095 ↗
Enrolled (actual)
40
Serious AEs
7.5%
Results posted
Jul 2021
Primary outcomePrimary: Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen — 39 Participants

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

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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