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

Titre officiel

mFOLFIRINOX or Gemcitabine / Nab-paclitaxel and Stereotactic Body Radiation Therapy Followed by Pancreatectomy for Patients With Borderline Resectable Pancreatic Adenocarcinoma. A Pilot Feasibility Study.

Sommaire:

Il s’agit d’un essai de faisabilité à groupe unique et mené dans un seul centre auprès de patients présentant un adénocarcinome pancréatique à la limite de la résécabilité et recevant une radiothérapie stéréotaxique corporelle (RSC) et une chimiothérapie par mFOLFIRINOX ou gemcitabine/nab-paclitaxel suivie d’une pancréatectomie.

Description de l'essai

Primary Outcome:

  • Proportion of patients eligible enrolled
Secondary Outcome:
  • Survival
  • Time to Progression
  • Overall Complications from surgery
  • Pathological response to chemo-radiation treatment
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.

Voir cet essai sur ClinicalTrials.gov

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