Low-dose Radiotherapy Plus Chemotherapy With Gem-based Doublets and Stereotactic Radiotherapy for Advanced Pancreatic Cancer
NCT ID: NCT02416609
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
44 participants
INTERVENTIONAL
2014-01-31
2024-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
LDR
LDR will be delivered during each cycle of Gem-based doublets
Gem-based doublets
4 cycles of Gem-based doublets
SBRT
SBRT will be administered after the fourth Gem-based doblet cycle, if no progression; three fractions will be administered
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LDR
LDR will be delivered during each cycle of Gem-based doublets
Gem-based doublets
4 cycles of Gem-based doublets
SBRT
SBRT will be administered after the fourth Gem-based doblet cycle, if no progression; three fractions will be administered
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Azienda Ospedaliero-Universitaria di Modena
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bruno Meduri
Medical Doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bruno Meduri, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria Policlinico di Modena
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, MO, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Bruno Meduri, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BMed1
Identifier Type: -
Identifier Source: org_study_id