Clinical Trial: NCT04452461 - My Cancer Genome

NCT04452461

Description:

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.

Related Conditions:

Pancreatic Adenocarcinoma

Recruiting Status:

Not yet recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04452461

Trial Eligibility

Document

Title

Brief Title: Pancreatic Adenocarcinoma Neoadjuvant Combination Chemotherapy and Stereotactic Body Radiation Therapy Before Surgery
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.

Clinical Trial IDs

ORG STUDY ID: 5076
NCT ID: NCT04452461

Conditions

Pancreatic Adenocarcinoma

Interventions

Drug	Synonyms	Arms
mFOLFIRINOX	5-FU, leucovorin, oxaliplatin	Single Arm Intervention
Gemcitabine / Nab-paclitaxel	gemcitabine / abraxane	Single Arm Intervention

Purpose

Detailed 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.

Trial Arms

Name	Type	Description	Interventions
Single Arm Intervention	Other	Chemotherapy: 6 cycles (three months) of IV combination chemotherapy with mFOLFIRINOX on day 1 followed by one week of rest (14-day cycle). Alternatively, patients will receive three months of gemcitabine / nab-paclitaxel. Re-staging CT scan with Carbohydrate Antigen (CA) 19-9 serum test. Radiation therapy with SBRT for 5 days. Re-staging CT scan with CA 19-9 serum test one week following the last day of SBRT . Staging laparoscopy to rule out occult metastatic disease is optional based on surgeon's preference. Pancreatectomy 4 weeks following the last day of SBRT as per standard of care. Adjuvant chemotherapy: as per standard of care. Clinical assessment and CT scan with CA 19-9 serum test at 4-month intervals until identification of cancer recurrence. Follow up of patients after 2 years every six months for up to 5 years following the initiation of treatment will be performed off-protocol as per standard of care.	mFOLFIRINOX Gemcitabine / Nab-paclitaxel

Eligibility Criteria

        Inclusion Criteria:

          -  1. 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

               1. Absolute neutrophil count (ANC) = or > 1500, platelets > 100K

               2. Total bilirubin <1.5x upper limit of normal (ULN)

               3. Alanine transaminase (ALT), Aspartate aminotransferase (AST) < 3 x ULN

               4. Creatinine <150umol/L

               5. Normal prothrombin time and international normalized ratio (INR) 5. Able to
                  provide written informed consent

        Exclusion Criteria:

          1. Proven metastatic disease (e.g. on imaging modality such as CT scan of the chest,
             abdomen and pelvis or MRI)

          2. Locally advanced pancreatic cancer (see definition section 3.3)

          3. Prior treatment with radiation therapy to the pancreas or associated field.

          4. Contraindications to receive chemotherapy

          5. History of cardiac disease including congestive heart failure (New York Heart
             Association class 2), active coronary artery disease or uncontrolled hypertension

          6. Concurrent ongoing systemic infections

          7. Illegal substance abuse, or social conditions that may interfere with patient's
             participation in the trial

          8. Pre-existing neuropathy

          9. Pregnant patients

Maximum Eligible Age:	79 Years
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Proportion of patients eligible enrolled
Time Frame:	18 months
Safety Issue:
Description:	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

Secondary Outcome Measures

Measure:	Survival
Time Frame:	24 months
Safety Issue:
Description:	Defined as percentage of patients alive at two years from enrolment.

Measure:	Time to Progression
Time Frame:	24 months from the initiation of chemotherapy (the length of the study)
Safety Issue:
Description:	Defined as the duration of time from enrolment to time to radiological evidence of disease progression or recurrence or death, whichever comes first.

Measure:	Overall Complications from surgery
Time Frame:	From date of surgery (POD=0) up to 90 postoperative days (POD=90)
Safety Issue:
Description:	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.

Measure:	Pathological response to chemo-radiation treatment
Time Frame:	From the date of the first chemotherapy to the date of surgery (around 4 months)
Safety Issue:
Description:	Pathological response to treatment will be classified as per protocol.

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Not yet recruiting
Lead Sponsor:	Hamilton Health Sciences Corporation

Last Updated

June 30, 2020

Clinical Trials /

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