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Stereotactic PAncreatic RadioTherapy Adjuvant Therapy


2021-07-06


2025-07


2025-07


50

Study Overview

Stereotactic PAncreatic RadioTherapy Adjuvant Therapy

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.

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.

  • Pancreas Cancer
  • RADIATION: Stereotactic Body Radiotherapy (SBRT)
  • 2957

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2021-09-08  

N/A  

2025-04-22  

2021-09-08  

N/A  

2025-04-24  

2021-09-14  

N/A  

2025-04  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Adjuvant Stereotactic Pancreatic Radiotherapy

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 deli

RADIATION: Stereotactic Body Radiotherapy (SBRT)

  • 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 in
Primary Outcome MeasuresMeasure DescriptionTime Frame
Local Recurrence Ratelocal recurrence rate in operated pancreatic cancer patients following adjuvant SBRT1 year
Secondary Outcome MeasuresMeasure DescriptionTime Frame
disease-free intervaldisease-free interval in operated pancreatic cancer patients following adjuvant SBRT1 year
Overall SurvivalOverall Survival in operated pancreatic cancer patients following adjuvant SBRT1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Varian Medical Systems

  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available