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
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UNKNOWN
NA
44 participants
INTERVENTIONAL
2014-01-31
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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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
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Eligibility Criteria
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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
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Azienda Ospedaliero-Universitaria di Modena
OTHER
Responsible Party
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Bruno Meduri
Medical Doctor
Principal Investigators
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Bruno Meduri, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria Policlinico di Modena
Locations
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Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, MO, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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
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BMed1
Identifier Type: -
Identifier Source: org_study_id
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