Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer

UMC Utrecht

Status and phase: Unknown; Phase 2

Conditions: Pancreatic Cancer

Treatments: Radiation: 24 Gy in 3 fractions

Study type: Interventional

Funder types: Other

Identifiers

NCT01898741

UMCU-12-628

Details and patient eligibility

About

Pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient treatment options for locally advanced tumors and metastasized patients. High dose radiotherapy with small margins seems feasible with current technical possibilities, e.g. by fiducial guided stereotactic radiotherapy. In this study, we want to evaluate safety and technical feasibility for cone beam CT guided stereotactic radiotherapy for locally advanced pancreatic carcinoma.

Full description

Objective of the study:

To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced pancreatic carcinoma

Study design:

Pilot study to determine safety and feasibility

Study population:

Patients with locally advanced pancreatic carcinoma, without distant metastasis

Intervention:

Patients will undergo endoscopic fiducial marker placement, and patients will get a custom-made individual corset. Radiotherapy will be delivered in three fractions of 8 Gy on an outpatient basis.

Primary study outcome:

The main study endpoint will be safety of the procedure, expressed in proportion of patients experiencing treatment-induced toxicity grade 3 or more according to the CTC-AE 4.0 due to the complete procedure within 90 days of the last radiation.

Secondary study outcome:

Other study parameters will be technical feasibility, treatment response, quality of life, overall survival, progression free survival, and rate of possible secondary resections

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Increased severe toxicity may occur due to the intervention, but treatment related toxicity should be limited due to strict dose constraints to the organs at risk (e.g. duodenum, stomach). Potential benefits may be pain relief, due to local control of the tumor, and a prolonged survival.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced pancreatic tumors (stage III) or medically inoperable patients with pancreatic cancer (stage I, II, or III)
• Not eligible for operation with curative intent
• >18 years
• Written informed consent

Exclusion criteria

• WHO performance status 3-4
• Expected life span <3 months
• Previous chemotherapy, pancreatic surgery or pancreatic radiotherapy
• Exclusion criteria for contrast enhanced MRI and/or CT scan, following the protocol of the department of radiology UMCU

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

irradiation

Experimental group

Description:

24 Gy in 3 fractions

Treatment:

Radiation: 24 Gy in 3 fractions