Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer

NCT03158779 | Completed Phase 2 DMC

• 1 other identifier: 1736
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT in patients with unresectable pancreatic cancer.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Evaluation of SBRT after induction CT with FOLFIRINOX or Gemcitabine-Abraxane in terms of overall survival time that will be calculated from the start of chemotherapy to death.

  2 years

Secondary Outcomes (4)

• Incidence of acute toxicities

  2 years

• Incidence of late toxicities

  4 years

• Freedom from local progression in treated patients

  2 years

• Progression free-survival of treated patients

  2 years

Study Arms (1)

SBRT and chemotherapy

EXPERIMENTAL

Participants received 4 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered. A 3-weeks break from chemotherapy and restaging with thorax-abdominal CT scan to confirm the absence of distant metastases was required before SBRT delivery. Before SBRT simulation, patients may will have implanted fiducial into the pancreatic tumor. The SBRT schedule will be \[6 x 9 Gy = 54 Gy\] delivered in consecutive days.

Combination Product: SBRT and chemotherapy

Interventions

SBRT and chemotherapy COMBINATION_PRODUCT

Patients affected by locally unresectable pancreatic cancer receive integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and a Stereotactic Body Radiation Therapy with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions.

SBRT and chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically and/or radiologically (CT scan and/or MRI scan and/or FDG-PET) proven unresectable locally advanced pancreatic cancer, discussed multidisciplinary by tumor board.
• Eighteen years of age or older,
• Minimum Karnofsky Performance Status of 70.
• Lesions cannot exceed 5 cm in maximum diameter.
• Absence of lymph-nodal metastases
• Patients received 4-6 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered.
• Baseline total body CT scan performed no more than 2 months before treatment.
• Placing fiducial markers through endoscopes is permitted (EUS-guided fiducials placement before the treatment).
• Acceptable organ and bone marrow function.
• Ability to maintain the set-up position during RT.
• All patients give informed consent and sign a study-specific informed consent form.

You may not qualify if:

• Metastatic disease
• Prior abdominal radiotherapy
• Other malignancies diagnosed within 5 years
• Gastric or duodenal obstruction.
• Concurrent chemotherapy.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery; Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Marta Scorsetti, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 18, 2017
• Study Start: May 10, 2017
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)