Clinical trial NCT02416609: Low-dose Radiotherapy Plus Chemotherapy With Gem-based Doublets and Stereotactic Radiotherapy for Advanced Pancreatic Cancer
Official title: Low-dose Radiotherapy as a Chemo-potentiator of a Induction Chemotherapy Regimen With Gem-based Doublets and Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Locally advanced pancreatic cancer
Stereotactic Body Radiotherapy
Chemopotentiator
Low dose radiotherapy
Hyper-Radiosensitivity
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Toxicity(scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0))
timeFrame: every 3 months, up to 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico di Modena
state: MO
Study officials:
affiliation: Azienda Ospedaliero-Universitaria Policlinico di Modena
name: Bruno Meduri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.