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Low-dose Radiotherapy Plus Chemotherapy With GemOx and Stereotactic Radiotherapy for Advanced Pancreatic Cancer (ORCHESTRATE)

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ClinicalTrials.gov Identifier: NCT02416609
Recruitment Status : Recruiting
First Posted : April 15, 2015
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Bruno Meduri, Azienda Ospedaliero-Universitaria di Modena

Brief Summary:
Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of a chemotherapy regimen with Gemcitabine and Oxaliplatin 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).

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: LDR Drug: Gem Drug: Ox Radiation: SBRT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-dose Radiotherapy as a Chemo-potentiator of a Induction Chemotherapy Regimen With GemOx and Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
Study Start Date : January 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gem Ox with LDR & sequential SBRT
Four GemOx cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered. Further two cycles of additional GemOx without LDR can be administered after SBRT.
Radiation: LDR
LDR will be delivered on days 1 and 2, 8 and 9 of each of four GemOx cycles
Other Name: Low dose radiotherapy

Drug: Gem
Gemcitabine (1.000 mg/sqm in a 30-minute infusion) will be administered on day 1-8 of each 21-day cycle, concurrent with LDR (for four cycles). Further two cycles of additional GemOx without LDR can be administered after SBRT
Other Name: Gemcitabine

Drug: Ox
Oxaliplatin (130 mg/sqm in a 2-hour infusion) will be administered on day 1 of each 21-day cycle, concurrent with LDR (for four cycles). Further two cycles of additional GemOx without LDR can be administered after SBRT
Other Name: Oxaliplatin

Radiation: SBRT
SBRT will be administered after the fourth GemOx cycle, if no progression; three fractions will be administered
Other Name: Steretactic body radiotherapy




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 year ]
    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


Secondary Outcome Measures :
  1. Toxicity(scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0)) [ Time Frame: every 3 months, up to 1 year ]
    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)

  2. Overall survival [ Time Frame: 1 year ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416609


Contacts
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Contact: Bruno Meduri, MD +393388878319 brunomeduri@gmail.com

Locations
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Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena Recruiting
Modena, MO, Italy, 41121
Contact: Bruno Meduri, MD    +393388878319    brunomeduri@gmail.com   
Principal Investigator: Bruno Meduri, MD         
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Modena
Investigators
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Principal Investigator: Bruno Meduri, MD Azienda Ospedaliero-Universitaria Policlinico di Modena

Publications:
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Responsible Party: Bruno Meduri, Medical Doctor, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier: NCT02416609     History of Changes
Other Study ID Numbers: BMed1
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Keywords provided by Bruno Meduri, Azienda Ospedaliero-Universitaria di Modena:
Locally advanced pancreatic cancer
Stereotactic Body Radiotherapy
Chemopotentiator
Low dose radiotherapy
Hyper-Radiosensitivity
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs