Clinical trial
An Adaptive Approach to Neoadjuvant Therapy to Maximize Resection Rates for Pancreatic Adenocarcinoma: A Phase II Trial
Name
UCCC-GI-20-02
Description
The purpose of this study is to determine if neoadjuvant therapy to increases resection rate for pancreatic adenocarcinoma.
Trial arms
Trial start
2021-03-17
Estimated PCD
2024-05-01
Trial end
2026-01-01
Status
Recruiting
Phase
Early phase I
Treatment
Folfirinox
Chemotherapy will begin with FOLFIRINOX - a standard regimen used in pancreatic cancer treatment, consisting of 5-fluorouracil (2400 mg/m2), irinotecan (180 mg/m2) and oxaliplatin (85 mg/m2). Treatment will continue for 2 cycles (4 doses), and then re-evaluation will be performed. If a decision to continue with FOLFIRINOX is made, it will be administered for another 4 cycles (8 doses).
Arms:
Neoadjuvant therapy
Other names:
5-fluorouracil, irinotecan and oxaliplatin
Gemcitabine
At the first planned analysis, if a switch is indicated based on prespecified criteria , gemcitabine (1000 mg/m2) and nab-paclitaxel (125 mg/m2) - another standard regimen in this setting - will be used. It will be administered for 4 cycles (12 doses).
Arms:
Neoadjuvant therapy
Other names:
gemcitabine and nab-paclitaxel
radiation therapy
Radiation therapy may be used prior to surgery, based on findings on the final pre-operative scan per standard of care. Radiation therapy will be delivered in patients with artery and venous involvement meeting the Intergroup definition for borderline resectable disease. Radiotherapy will be delivered via a hypofractionated approach over 10 fractions and will include target volumes to the primary tumor and elective coverage of vascular structures at risk. Radiation will be delivered with concurrent chemotherapy.
Arms:
Neoadjuvant therapy
Pancreatectomy
Pancreatectomy should occur within 4 to 8 weeks after the last dose of preoperative chemotherapy. Staging laparoscopy may be performed at the time of planned laparotomy but is not required. Either standard or pylorus-preserving pancreaticoduodenectomy, distal subtotal pancreatectomy, or total pancreatectomy may be performed. Surgical drains and enteral tubes (e.g. gastrostomy and/or jejunostomy tubes) may be placed at the discretion of the operating surgeon.
Arms:
Neoadjuvant therapy
Size
32
Primary endpoint
Measuring the proportion of patients undergoing surgical resection using historical data compared to 32 patients in current study.
16 months
Eligibility criteria
Inclusion Criteria:
* Diagnosis of pancreatic carcinoma or adenocarcinoma confirmed by tissue. Histologies other than carcinoma or adenocarcinoma are not allowed.
* Resectable or borderline resectable primary tumor, evaluated on a baseline contrast-enhanced CT or MRI scan (CT Chest/Abdomen/Pelvis with contrast is preferred; if MRI used at baseline, then follow up with MRI as well), and defined using Intergroup criteria:
* Tumor vessel wall interface 0-360 for portal and superior mesenteric veins.
* Tumor vessel wall interface \<180 for celiac, common hepatic, and superior mesenteric arteries.
* No suspicious metastatic lesions (no visceral lesions, no enlarged nodes outside the surgical basin).
* Age ≥18 years.
* ECOG performance status ≤ 1.
* No prior therapy for index pancreatic cancer.
* Patients must have adequate organ and marrow function as defined in protocol
* Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Patients with a prior malignancy (with all treatment completed at least 2 years prior to enrollment) whose natural history does not have the potential to interfere with the safety or efficacy assessment of this study are eligible.
* Women of child-bearing potential and fertile men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of active treatment.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients with uncontrolled intercurrent illness or comorbidities that would, in the opinion of the treating physician, prevent receipt of standard of care chemotherapy, radiation or surgery.
* Pregnant women or women who are breastfeeding are excluded from this study.
* Patients who are currently receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.
* Patients with psychiatric illness/social situations that would limit compliance with study requirements, per the PI's discretion.
* Patients who, in the opinion of the PI, will be unable to adhere to study requirements.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}
Updated at
2023-09-15
1 organization
1 product
1 drug
1 indication
Organization
University of CincinnatiProduct
FolfirinoxIndication
Pancreatic CancerDrug
Gemcitabine