Pancreatic Adenocarcinoma Neoadjuvant Combination Chemotherapy and Stereotactic Body Radiation Therapy Before Surgery

  • STATUS
    Recruiting
  • End date
    May 1, 2026
  • participants needed
    30
  • sponsor
    Hamilton Health Sciences Corporation
Updated on 18 September 2021

Summary

This is a single-arm, single-center feasibility trial of patients with borderline resectable pancreatic adenocarcinoma receiving radiation therapy with Stereotactic body radiation therapy (SBRT) and chemotherapy with mFOLFIRINOX or gemcitabine / nab-paclitaxel followed by pancreatectomy.

Description

Borderline resectable pancreatic adenocarcinoma infiltrates into adjacent vascular structures to an extent such that complete macroscopic resection is technically feasible, but an R0 resection poses a challenge when surgery is the primary therapy. Therefore, a different management strategy may be beneficial.

The primary outcome of the PANCREAS trial is defined as the proportion of eligible patients enrolled in the study over an 18-month period and the proportion of patients who complete the protocol (neoadjuvant therapy and pancreatectomy). Certain modifications of the neoadjuvant therapy protocol are expected and allowed, and the primary feasibility outcome will be one of the following: stop, main study non-feasible; continue with protocol modifications; or continue without modification. A safety analysis will be performed after first 15 patients are enrolled and complete neoadjuvant therapy and surgery. Patients enrolled in this trial will undergo interventions in the following order: neoadjuvant chemotherapy, re-staging CT scan, SBRT, re-staging CT scan, pancreatectomy and adjuvant chemotherapy. Postoperative mortality will be recorded up to 90 days after surgery. Patients will be followed every four months with a CT scan of the chest/abdomen for two years after resection or until evidence of disease recurrence. Patients who do not undergo surgical resection will be followed for two years after accrual (duration of study period) or until evidence of disease progression or death.

Details
Condition Pancreatic Adenocarcinoma
Treatment stereotactic body radiation therapy, mFOLFIRINOX, Gemcitabine / Nab-paclitaxel
Clinical Study IdentifierNCT04452461
SponsorHamilton Health Sciences Corporation
Last Modified on18 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Men and women 18 years of age or older who present with biopsy proven borderline resectable pancreatic adenocarcinoma who are medically fit for surgery as per assessment by treating surgeon. 2. Age 79 years 3. Eastern Cooperative Oncology Group (ECOG) performance status 1 4\. Normal bone marrow and organ function
Absolute neutrophil count (ANC) = or > 1500, platelets > 100K
Total bilirubin <1.5x upper limit of normal (ULN)
Alanine transaminase (ALT), Aspartate aminotransferase (AST) < 3 x ULN
Creatinine <150umol/L
Normal prothrombin time and international normalized ratio (INR) 5. Able to provide written informed consent

Exclusion Criteria

Proven metastatic disease (e.g. on imaging modality such as CT scan of the chest, abdomen and pelvis or MRI)
Locally advanced pancreatic cancer (see definition section 3.3)
Prior treatment with radiation therapy to the pancreas or associated field
Contraindications to receive chemotherapy
History of cardiac disease including congestive heart failure (New York Heart Association class 2), active coronary artery disease or uncontrolled hypertension
Concurrent ongoing systemic infections
Illegal substance abuse, or social conditions that may interfere with patient's participation in the trial
Pre-existing neuropathy
Pregnant patients
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