Pancreatic Adenocarcinoma Neoadjuvant Combination Chemotherapy and Stereotactic Body Radiation Therapy Before Surgery (PANCREAS)
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|ClinicalTrials.gov Identifier: NCT04452461|
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: mFOLFIRINOX Drug: Gemcitabine / Nab-paclitaxel Radiation: Stereotactic body radiation therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||mFOLFIRINOX or Gemcitabine / Nab-paclitaxel and Stereotactic Body Radiation Therapy Followed by Pancreatectomy for Patients With Borderline Resectable Pancreatic Adenocarcinoma. A Pilot Feasibility Study.|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||May 1, 2026|
Single Arm Intervention
mFOLFIRINOX, including: Oxaliplatin 85 mg/m2 IV over 2 hours, Leucovorin 400mg/m2 IV over 2 hours, Irinotecan at 150 mg/m2 IV over 90 min, 5-Fluoruracil continuous infusion of 2400 mg/m2 IV over 46h.
Drug: Gemcitabine / Nab-paclitaxel
Both drugs are administered once weekly for three weeks (days 1, 8, 15) followed by a week of rest (28-day cycle) for 3 cycles prior to imaging. Gemcitabine: 1000 mg/m2 intravenous infusion over 30 to 40 minutes. Nab-paclitaxel: 125 mg/m2 intravenous infusion over 30 to 40 minutes.
Other Name: gemcitabine / abraxane
Radiation: Stereotactic body radiation therapy
The radiation dose will be limited to 30 Gy maximum for the small bowel. For other organs, we will follow the "as low as reasonably achievable" principle. Radiation quality assurance will be performed for all treatment plans. Volumes of tumour obtained on CT images at 1.25 mm slice thickness will be reconstructed into a three-dimensional image set for SBRT planning. The SBRT will deliver a radiation dose of 36 Gy in three fractions with 12 Gy per fraction to the isodose line best encompassing the planning target volume, including a 2 mm expansion around the gross tumour.
Other Name: SBRT
- Proportion of patients eligible enrolled [ Time Frame: 18 months ]
Over an 18-month period The proportion of patients who complete the protocol (neoadjuvant therapy and pancreatectomy). As described, there are certain modifications of the neoadjuvant therapy protocol that are expected and allowed. The primary feasibility outcome will be one of the following:
- Stop, main study non-feasible: 1) estimated proportion of eligible patients enrolled <40% or 2) estimated proportion of enrolled patients who complete the protocol (neoadjuvant therapy and pancreatectomy) <40%.
- Continue with protocol modifications: 1) estimated proportion of eligible patients enrolled between 40-59% or 2) estimated proportion of enrolled patients who complete the protocol (neoadjuvant therapy and pancreatectomy) 40-59%.
- Continue without modification: 1) estimated proportion of eligible patients enrolled equal to or greater than 60% or estimated proportion of enrolled patients who complete the protocol (neoadjuv
- Survival [ Time Frame: 24 months ]Defined as percentage of patients alive at two years from enrolment.
- Time to Progression [ Time Frame: 24 months from the initiation of chemotherapy (the length of the study) ]Defined as the duration of time from enrolment to time to radiological evidence of disease progression or recurrence or death, whichever comes first.
- Overall Complications from surgery [ Time Frame: From date of surgery (POD=0) up to 90 postoperative days (POD=90) ]Occurrence of any postoperative complication (major or minor) from surgery following each patient's hospital stay and up to 90 days from the initial operation.
- Pathological response to chemo-radiation treatment [ Time Frame: From the date of the first chemotherapy to the date of surgery (around 4 months) ]Pathological response to treatment will be classified as per protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452461
|Contact: Pablo E Serrano, MD||905-521-2100 ext email@example.com|
|Contact: Leyo Ruo, MDfirstname.lastname@example.org|
|Hamilton, Ontario, Canada, L8V1C3|
|Contact: Pablo E Serrano, MD 905-521-2100 ext 43872 email@example.com|
|Sub-Investigator: Leyo Ruo, MD|
|Sub-Investigator: Brandon Meyers, MD|
|Sub-Investigator: Christian van der Pol, MD|
|Sub-Investigator: Tariq Aziz, MD|
|Sub-Investigator: Sameer Parpia, PhD|
|Sub-Investigator: Kimmen Quan, MD|
|Principal Investigator:||Pablo E Serrano, MD||McMaster University|