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Stereotactic PAncreatic RadioTherapy Adjuvant Therapy (SPARTA)

Primary Purpose

Pancreas Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy (SBRT)
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Surgically treated T1-T4 adenocarcinoma with or without prior chemotherapy AND close (<2.5mm)/positive resection margin AND/OR N1 staging at lymphadenectomy
  • ECOG performance status <2
  • Age > 18
  • Estimated life expectancy > 6 months
  • Ability to provide written informed consent
  • Cardiovascular comorbidities limiting life expectancy

Exclusion Criteria:

  • Metastatic disease
  • Biliary tract or neuroendocrine neuroplasm
  • History of malignancies except for non-melanoma cutaneous tumors

Sites / Locations

  • Humanitas Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adjuvant Stereotactic Pancreatic Radiotherapy

Arm Description

Postoperative Stereotactic Body Radiation Therapy (SBRT) after pancreatic tumor resection. Stereotactic Body Radiotherapy (SBRT) is a novel radiotherapy technique consisting of highly focused irradiation with a steep dose gradient, thus allowing the delivery of ablative radiation doses and significant sparing of proximity critical structures. Higher doses per fraction allows for more intensive treatments and shorter duration of the radiation course.

Outcomes

Primary Outcome Measures

Local Recurrence Rate
local recurrence rate in operated pancreatic cancer patients following adjuvant SBRT

Secondary Outcome Measures

disease-free interval
disease-free interval in operated pancreatic cancer patients following adjuvant SBRT
Overall Survival
Overall Survival in operated pancreatic cancer patients following adjuvant SBRT

Full Information

First Posted
September 8, 2021
Last Updated
September 14, 2022
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT05043857
Brief Title
Stereotactic PAncreatic RadioTherapy Adjuvant Therapy
Acronym
SPARTA
Official Title
Stereotactic PAncreatic RadioTherapy Adjuvant Therapy (SPARTA): Phase II Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
While surgery is considered the only potentially curative therapy for pancreatic cancer, 5-year overall survival (OS) is typically <25%. Following surgical resection of pancreatic cancer, adjuvant conventionally fractionated RT (CRT, delivering 45-54 Gy in 1.8-2.0 Gy per fraction) with 5-FU chemotherapy is recommended in high-risk patients (positive lymph nodes and/or R1-R2 resection margin status). However, the benefit of CRT in this setting is controversial due to lack of prospective positive data. Moreover, duration of treatment course (delaying initiation of more effective chemotherapy schedules), insufficient dose delivery due potential radiation-related severe toxicity to proximity organs represents a serious limitation to treatment efficacy. Stereotactic Body Radiotherapy (SBRT) is a novel radiotherapy technique consisting of highly focused irradiation with a steep dose gradient, thus allowing the delivery of ablative radiation doses and significant sparing of proximity critical structures. Higher doses per fraction allows for more intensive treatments and shorter duration of the radiation course.
Detailed Description
Pancreatic carcinoma is expected to become in the next 10 years the second leading cause of cancer-related mortality. Resection is the only treatment with the potential to achieve long-term survival, although expected survival at 5 year is <25%: postoperative use of local and systemic adjuvant treatments has been proposed to improve outcome While the efficacy of adjuvant chemotherapy, in parrticular multiagent chemotherapy, has been established, the potential impact of chemoradiation in the adjuvant setting is still controversial. However, its use in patients with high risk features such as nodal involvement and close or positive margins may be of interest. Adjuvant chemoradiation, when clinically indicated, is usually delivered in a 6 week treatment course in association with concurrent dose-adapted chemotherapy, implying the necessity to interrupt more effective multi-agent chemotherapy schedules due to risk of increased toxicity. It has been proposed that higher radiotherapy doses may result in improved outcome although a potential detrimental effect on survival of dose escalation >55 Gy with conventional fractionation, possibly related to increased toxicity, has been reported. Stereotactic Body Radiotherapy (SBRT) is a novel radiotherapy technique consisting of highly focused irradiation with a steep dose gradient, thus allowing the delivery of ablative radiation doses and significant sparing of proximity critical structures. Higher doses per fraction allows for more intensive treatments and shorter duration of the radiation course. In a retrospective study by Rwigema et al, adjuvant pancreatic SBRT was shown to be a safe and feasible treatment option for patients with high-risk pancreatic adenocarcinoma.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant Stereotactic Pancreatic Radiotherapy
Arm Type
Experimental
Arm Description
Postoperative Stereotactic Body Radiation Therapy (SBRT) after pancreatic tumor resection. Stereotactic Body Radiotherapy (SBRT) is a novel radiotherapy technique consisting of highly focused irradiation with a steep dose gradient, thus allowing the delivery of ablative radiation doses and significant sparing of proximity critical structures. Higher doses per fraction allows for more intensive treatments and shorter duration of the radiation course.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy (SBRT)
Intervention Description
Postoperative Stereotactic Body Radiation Therapy (SBRT) after tumor resection targeting 2 volumes CTV1 (clips+isotropic 5mm expansion, edited on anatomic barriers): receiving 40 Gy in 5 fractions of 8 Gy CTV2 (CTV1+ anisotropic 10-15 mm expansion including corresponding vessels, retroperitoneum posterior to the SMV/SMA or celiac axis, edited on anatomic barriers): receiving 30 Gy in 5 fractions of 6 Gy.
Primary Outcome Measure Information:
Title
Local Recurrence Rate
Description
local recurrence rate in operated pancreatic cancer patients following adjuvant SBRT
Time Frame
1 year
Secondary Outcome Measure Information:
Title
disease-free interval
Description
disease-free interval in operated pancreatic cancer patients following adjuvant SBRT
Time Frame
1 year
Title
Overall Survival
Description
Overall Survival in operated pancreatic cancer patients following adjuvant SBRT
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Surgically treated T1-T4 adenocarcinoma with or without prior chemotherapy AND close (<2.5mm)/positive resection margin AND/OR N1 staging at lymphadenectomy ECOG performance status <2 Age > 18 Estimated life expectancy > 6 months Ability to provide written informed consent Cardiovascular comorbidities limiting life expectancy Exclusion Criteria: Metastatic disease Biliary tract or neuroendocrine neuroplasm History of malignancies except for non-melanoma cutaneous tumors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Scorsetti, Prof
Phone
+390282248523
Email
marta.scorsetti@hunimed.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Federico Fornasier, M.Sc
Phone
+390282247026
Email
federico.fornasier@humanitas.it
Facility Information:
Facility Name
Humanitas Research Hospital
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiziana Comito, MD
Phone
+390282247244
Email
tiziana.comito@humanitas.it
First Name & Middle Initial & Last Name & Degree
Federico fornasier, M.Sc
Phone
+390282247026
Email
federico.fornasier@humanitas.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Stereotactic PAncreatic RadioTherapy Adjuvant Therapy

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