Clinical trial NCT01304160: Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
Official title: Phase I/II Study to Investigate the Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Unresectable Pancreatic Cancer
Keywords: pancreatic cancer
stereotactic body radiotherapy
radiation
gemcitabine
locally advanced
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
First posted: 2011-02-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of stereotactic radiation therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients with locally advanced pancreatic cancer.

Detailed description: The purpose of this phase I/II study is to evaluate the efficacy and toxicity of a different stereotactic body radiation therapy regimen combined with gemcitabine. In the present study, 5 daily fractions of 6 Gray will be given over two weeks. Stereotactic body radiation therapy will be given with the Cyberknife system. This treatment technique allows to give a higher dose to the tumor as compared to conventional external beam radiation while lowering the dose to the normal tissues around. This treatment system is also capable of following the motion that the pancreas assumes during respiration as well as during treatment. This enables us to reduce the margin of security and further reduce dose to surrounding normal tissue.

The primary objective of this study is to evaluate acute and chronic toxicity of this regimen of stereotactic radiation therapy followed by gemcitabine. Quality of life, local control and overall survival will also be evaluated.

Eligibility criteria: Inclusion Criteria:

* Pancreatic Adenocarcinoma, histologically and/or cytologically proven
* Locally advanced pancreatic cancer, surgically non resectable
* No distant metastasis
* Work-up including medical history, physical exam, biochemistry, chest X-ray, CT-scan of abdomen and pelvis
* ECOG performance status : ≤ 2
* Primary tumor visible on CT-scan
* Maximum tumor diameter of 6 cm (including primary tumor and regional lymph nodes)
* White blood cell count \> 3000 /uL, Neutrophils \> 1500 /uL, Platelets \> 100 000/uL, Hemoglobin \> 95 mg/L, Total bilirubin \< 1,5 normal limit, AST/ALT \< 2,5 normal limit, normal creatinin
* ≥ 18 years of age
* Signed informed consent

Exclusion Criteria:

* Prior abdominal radiation therapy
* Connective tissue disease (scleroderma, lupus)
* Prior treatment for pancreatic cancer such as radiation therapy, chemotherapy or surgery.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: one year
Secondary outcomes:
measure: Quality of life
timeFrame: 3 monthly
measure: Local control
timeFrame: 3 monthly
measure: overall survival
timeFrame: one and two year
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Marie-Pierre Campeau, MD
role: PRINCIPAL_INVESTIGATOR
References: