Low-dose Radiotherapy Plus Chemotherapy With Gem-based Doublets And Stereotactic Radiotherapy For Advanced Pancreatic Cancer

Study Overview

Low-dose Radiotherapy Plus Chemotherapy With Gem-based Doublets and Stereotactic Radiotherapy for Advanced Pancreatic Cancer

Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of a chemotherapy regimen with Gem-based doublets administered sequentially with stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).

N/A

Pancreatic Cancer

RADIATION: LDR
DRUG: Gem-based doublets
RADIATION: SBRT

BMed1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-04-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-12-08
First Submitted that Met QC Criteria 2015-04-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-12-12
First Posted (ACTUAL) 2015-04-15	Results First Posted N/A	Last Verified 2022-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Gem-based doublets with LDR & sequential SBRT Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.	RADIATION: LDR LDR will be delivered during each cycle of Gem-based doublets DRUG: Gem-based doublets 4 cycles of Gem-based doublets RADIATION: SBRT SBRT will be administered after the fourth Gem-based doblet cycle, if no progression; three fractions will be administered

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gem-based doublets with LDR & sequential SBRT

Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.

RADIATION: LDR

LDR will be delivered during each cycle of Gem-based doublets

DRUG: Gem-based doublets

4 cycles of Gem-based doublets

RADIATION: SBRT

SBRT will be administered after the fourth Gem-based doblet cycle, if no progression; three fractions will be administered

Primary Outcome Measures	Measure Description	Time Frame
Progression-free survival	defined as the time from the initiation of therapy to the time of first event (local, regional or distant progression or death due to any cause). Patients without any such event at the time of data analysis will be censored at the last date they were known to be event-free. Patients with no tumor assessments after baseline will be censored at day 1	1 year

Secondary Outcome Measures	Measure Description	Time Frame
Toxicity(scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0))	Acute gastrointestinal toxicity is defined as adverse events occurring <3 months after SBRT; long-term toxicity was defined as those occurring after 3 months. Toxicity is scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0)	every 3 months, up to 1 year
Overall survival	defined as the time from the date of initiation of therapy to date of death due to any cause. Patients who is alive on the date of last follow-up were censored on that date	1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Bruno Meduri, MD

Phone Number: +393388878319

Email: brunomeduri@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Pathologically confirmed adenocarcinoma of the pancreas
Patients with unresectable disease based on institutional standardized criteria of unresectability or patients whose disease appeared potentially resectable on axial CT imaging but were found unresectable at surgery
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Age ≥ 18
Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting treatment
Patients with radiographically assessable disease
Adequate bone marrow, hepatic and renal function: -Hemoglobin >10.0 g/dL, absolute neutrophil count > 1.5 x 10^9/L, platelet count > 100 x 10^9/L. -Aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) should be ≤ 3 x upper limit of normal (ULN). -Total bilirubin < 2 mg/dL. Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should decrease to < 2 mg/dL prior to study entry. - Creatinine < 3 mg/dL or Creatinine clearance > 40 mL/min (calculated according to Cockroft and Gault)

Evidence of metastatic disease in the major viscera or peritoneal seeding or ascites
Gastric or duodenal obstruction
Previous peripheral neuropathy
Previous irradiation to the planned field; previous chemotherapy for pancreatic cancer
Malignancy (within the past two years) except non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Bruno Meduri, MD, Azienda Ospedaliero-Universitaria Policlinico di Modena

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Mantini G, Valentini V, Meduri B, Margaritora S, Balducci M, Micciche F, Nardone L, De Rose F, Cesario A, Larici AR, Maggi F, Calcagni ML, Granone P. Low-dose radiotherapy as a chemo-potentiator of a chemotherapy regimen with pemetrexed for recurrent non-small-cell lung cancer: a prospective phase II study. Radiother Oncol. 2012 Nov;105(2):161-6. doi: 10.1016/j.radonc.2012.09.006. Epub 2012 Oct 12.
Regine WF, Hanna N, Garofalo MC, Doyle A, Arnold S, Kataria R, Sims J, Tan M, Mohiuddin M. Low-dose radiotherapy as a chemopotentiator of gemcitabine in tumors of the pancreas or small bowel: a phase I study exploring a new treatment paradigm. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):172-7. doi: 10.1016/j.ijrobp.2006.11.045. Epub 2007 Feb 2.
Mahadevan A, Jain S, Goldstein M, Miksad R, Pleskow D, Sawhney M, Brennan D, Callery M, Vollmer C. Stereotactic body radiotherapy and gemcitabine for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):735-42. doi: 10.1016/j.ijrobp.2009.08.046. Epub 2010 Feb 18.
Valentini V, Massaccesi M, Balducci M, Mantini G, Micciche F, Mattiucci GC, Dinapoli N, Meduri B, D'Agostino GR, Salvi G, Nardone L. Low-dose hyperradiosensitivity: is there a place for future investigation in clinical settings? Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):535-9. doi: 10.1016/j.ijrobp.2009.02.075. Epub 2009 Jun 18.

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