Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Gemcitabine

Paclitaxel

Irinotecan

Fluorouracil

Albumin-Bound Paclitaxel

Pancrelipase

Pancreatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.

Systemic chemotherapy followed by chemoradiation, followed by definitive surgery

Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles

Gemcitabine and nanoparticle albumin bound paclitaxel

5-fluorouracil and irinotecan

Pre-operative chemoradiation to 40 Gy in 20 fractions

Preoperative chemoradiation

Definitive surgical resection of primary tumor

Definitive resection

Peter Kebbekus, MD, PhD

Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.

Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).

All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.

All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 \& 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.

After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.

Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.

Patients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.

Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla

Phase 2 Evaluation of a Community-Based Multi-modality Management Algorithm for Clinically Non-metastatic Ductal Adenocarcinoma of the Exocrine Pancreas or Ampulla

We will make unidentified dataset available for electronic download.

Percentage of patients alive and free of detectable disease 1 yr from start of treatment

Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection)

Time to death from any cause measured from start of treatment

Essentia Health

Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.

Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles

Definitive resection: Definitive surgical resection of primary tumor

Resectable, Low Risk

Systemic chemotherapy followed by chemoradiation, followed by definitive surgery

Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles

5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles

Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions

Definitive resection: Definitive surgical resection of primary tumor

Locally Advanced

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Dr. Bret Friday

Due to excessive toxicity of study regimen, the study was permanently closed prior to data analysis.

Spots Global Cancer Trial Database for definitive resection