Clinical Phase II Clinical Study Evaluating the Toxicity and Efficacy of mFOLFIRINOX Associated With SBRT (Stereotactic Radiotherapy) in Patients With Unresectable Locally Advanced Pancreatic Cancer

NCT03891472 | Completed Phase 2

• 1 other identifier: KNW/0022/KB1/71/I/16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Primary goal: Improvement of the therapeutic index by reducing the toxicity of treatment and increasing local control of the cancer process while evaluating the possibility of conversion to the surgical status. Secondary targets:

• Survival rate (OS) assessment in patients treated with mFOLFIRINOX + SBRT
• Assessment of quality of life using questionnaires: EQ-5D, EORTC (QLQ-C30) and pancreatic cancer-specific QLQ PAS module 26
• Early toxicity \<3 months after completion of SBRT treatment.
• Percentage of local control (1-year)

Conditions

Cancer of Pancreas; Unresectable Pancreatic Cancer; Chemotherapy Effect; SBRT

Keywords

mFOLFIRINOX; SBRT; Unresectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Improvement of the therapeutic index.

  Improvement of the therapeutic index by reducing the toxicity of treatment and increasing local control of the cancer process while evaluating the possibility of conversion to the surgical status.

  24 months.

• Improvement of the overall survival.

  Improvement of the overall survival by new treatment method.

  60 months.

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.

Interventions

Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy. DRUG

mFOLFIRINOX \> SBRT \> mFOLFIRINOX \> Surgical Intervention

Also known as: mFOLFIRINOX (Oxaliplatin, Irinotecan, Fluorouracil), SBRT (Stereotactic Body Radiation Therapy), Surgical Intervention (Pancreatectomy)

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing informed consent for treatment.
• Age\> = 18 years.
• Patients with histopathological diagnosis of adenocarcinoma of the pancreas.
• Advanced disease referred to as locally advanced definitive non-resetable, non-metastatic pancreatic cancer.
• No prior systemic treatment due to pancreatic adenocarcinoma
• No prior radiotherapy in the abdominal area
• No prior radical surgical treatment due to pancreatic adenocarcinoma (palliative surgical procedures such as bypass surgery or biliary tract surgery are acceptable).
• ECOG 0 or 1.
• Expected survival time in excess of 12 weeks.
• Adequate organ performance based on laboratory blood tests.

You may not qualify if:

• Patients diagnosed with other types of pancreatic cancer than adenocarcinomas (eg neuroendocrine cancer).
• Advanced disease that allows primary surgical treatment.
• Borderline pancreatic cancer (BRPC) disease.
• The presence of metastases.
• Previous systemic treatment because of pancreatic adenocarcinoma.
• Preoperative radiotherapy in the abdominal area.
• Previous radical surgery for pancreatic adenocarcinoma.
• Large surgical procedure with the exception of diagnostic biopsies within the last 4 weeks after the start of treatment and / or patients who have not fully recovered after surgery.
• Heart failure (NYHA Class II, III or IV)
• Hemodynamic instability in the course of coronary and / or valvular heart disease and / or hypertension and / or other clinical conditions (eg uncontrolled diabetes mellitus).
• Clinically relevant cardiac arrhythmias requiring treatment.
• Respiratory failure associated with other co-morbidities.
• Serious psychiatric illnesses, which, in the researcher's opinion, could have a significant negative impact on the safety of the treatment.
• Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
• Transplanted organ transplant including allogeneic bone marrow transplant.

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

UCK Katowice

Katowice, Silesian Voivodeship, 40-514, Poland

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; Irinotecan; Fluorouracil; Radiosurgery; Surgical Procedures, Operative; Pancreatectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Investigative Techniques; Digestive System Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 27, 2019
• Study Start: January 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

PL (1)