NCT03460925

Brief Summary

Evaluation of clinical response in terms of resectability of patients with locally advanced pancreatic cancer treated with neoadjuvant chemotherapy plus stereotactic body radiotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable pancreatic-cancer

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

1.7 years

First QC Date

March 5, 2018

Last Update Submit

May 28, 2018

Conditions

Pancreatic CancerStereotactic Body Radiotherapy

Keywords

pancreatic cancerstereotactic body radiotherapyresectability

Outcome Measures

Primary Outcomes (1)

  • Clinical response to the treatment in terms of resectability

    Percentage of patients with pancreatic cancer judged to be inoperable who have undergone surgical treatment after neoadjuvant chemotherapy plus stereotactic body radiotherapy. Response is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria) by a multidisciplinary team of surgeons, radiologist, oncologist, radiation oncologist according to resectability criteria NCCN v. 2017.

    24 months

Secondary Outcomes (4)

  • Overall survival

    24 months

  • Progression free survival

    24 months

  • Toxicity

    24 months

  • Quality of life

    24 months

Study Arms (1)

SBRT plus chemotherapy

EXPERIMENTAL

Patients with unresectable or "borderline resectable" locally advanced pancreatic carcinoma at time of diagnosis

Radiation: SBRT plus chemotherapy

Interventions

SBRT plus chemotherapyRADIATION

Neoadjuvant stereotactic body radiotherapy (SBRT, 30 Gy in 5 fractions) plus chemotherapy with Folfirinox

SBRT plus chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histological diagnosis of locally advanced pancreatic carcinoma, not upfront surgically treated (according to NCCN resectability criteria), without distant metastases
  • NCCN criteria resectability status
  • patient's age, performance status, possible presence of comorbidity should also be considered to decide the optimal approach (upfront surgery versus neoadjuvant treatment).
  • If the chemotherapy treatment induces the disease to a condition of resectability, the patient will undergo a surgical evaluation
  • indication for radiotherapy treatment
  • ECOG 0-2
  • obtaining informed consent
  • not pregnant or breastfeeding

You may not qualify if:

  • ECOG\> 2
  • presence of internal diseases for which radiotherapy is contraindicated, or diseases of the connective system, or gastric or duodenal ulcer in progress or acute diverticulitis, ulcerative colitis
  • comorbidity which in the opinion of the referring physician may constitute a risk for participation in the study
  • lack of availability for clinical-instrumental follow-up
  • previous abdominal radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

RadiosurgeryDrug Therapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Alessio G Morganti, MD

    Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy

    STUDY DIRECTOR

Central Study Contacts

Alessio G Morganti, MD

CONTACT

+390512143564rt.unibo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 9, 2018

Study Start

May 2, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

IT(1)