Recruiting
Phase 2

Neoadjuvant Chemotherapy

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT04452461

Conditions

Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

mFOLFIRINOX

Gemcitabine / Nab-paclitaxel

Study Details

Brief summary:

This is a single-arm, single-center feasibility trial of patients with borderline resectable pancreatic adenocarcinoma receiving chemotherapy with mFOLFIRINOX or gemcitabine / nab-paclitaxel followed by pancreatectomy.

Conditions

Pancreatic Adenocarcinoma

Study ID

NCT04452461

Start date

Mar 1, 2021

Status verified date

Oct, 2024

Completion date

May 1, 2026

Anticipated

Primary completion date

Dec 12, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single Arm Intervention

1. 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.
2. Re-staging CT scan with Carbohydrate Antigen (CA) 19-9 serum test.
3. Staging laparoscopy to rule out occult metastatic disease is optional based on surgeon's preference.

5. Pancreatectomy 4 weeks following the last day of Chemotherapy as per standard of care.

6. Adjuvant chemotherapy: as per standard of care. 7. Clinical assessment and CT scan with CA 19-9 serum test at 4-month intervals until identification of cancer recurrence.

8. 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.

Interventions

mFOLFIRINOX

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.

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.

Primary outcome measure

  • Proportion of patients eligible enrolled [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Locations

Juravinski Hospital

Recruiting

Hamilton, Ontario, Canada, L8V1C3

Contacts

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Oct 10, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2024-10-10.