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

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

LDR

Gem-based doublets

SBRT

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Locally advanced pancreatic cancer, Stereotactic Body Radiotherapy, Chemopotentiator, Low dose radiotherapy, Hyper-Radiosensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Azienda Ospedaliero-Universitaria Policlinico di ModenaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gem-based doublets with LDR & sequential SBRT

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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

Full Information

NCT ID

NCT02416609

First Posted

April 7, 2015

Last Updated

December 8, 2022

Sponsor

Azienda Ospedaliero-Universitaria di Modena

1. Study Identification

Unique Protocol Identification Number

NCT02416609

Brief Title

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

Acronym

ORCHESTRATE

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 2014 (undefined)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliero-Universitaria di Modena

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Locally advanced pancreatic cancer, Stereotactic Body Radiotherapy, Chemopotentiator, Low dose radiotherapy, Hyper-Radiosensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gem-based doublets with LDR & sequential SBRT

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

LDR

Other Intervention Name(s)

Low dose radiotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gem-based doublets

Intervention Description

4 cycles of Gem-based doublets

Intervention Type

Radiation

Intervention Name(s)

SBRT

Other Intervention Name(s)

Steretactic body radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Toxicity(scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0))

Description

Time Frame

every 3 months, up to 1 year

Title

Overall survival

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bruno Meduri, MD

Phone

+393388878319

brunomeduri@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruno Meduri, MD

Organizational Affiliation

Azienda Ospedaliero-Universitaria Policlinico di Modena

Official's Role

Principal Investigator

Facility Information:

Facility Name

Azienda Ospedaliero-Universitaria Policlinico di Modena

City

Modena

State/Province

ZIP/Postal Code

41121

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruno Meduri, MD

Phone

+393388878319

brunomeduri@gmail.com

First Name & Middle Initial & Last Name & Degree

Bruno Meduri, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23068709

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.

Results Reference

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PubMed Identifier

17276612

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.

Results Reference

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PubMed Identifier

20171803

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.

Results Reference

background

PubMed Identifier

19540061

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.

Results Reference

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

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