Pancreatic Cancer, Unresectable Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, stereotactic body radiotherapy, radiation, gemcitabine, locally advanced
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.
Interventions
RADIATIONstereotactic body radiotherapy
30Gray in 5 fractions
Sponsors
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | one year | Acute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 3 monthly | Quality of life will be evaluated with the EORTC QLQ-C30 questionnaire |
| Local control | 3 monthly | Local control will be assessed with 3 monthly CT-scans of the abdomen. RECIST criteria will be used to evaluate local control. |
| overall survival | one and two year | — |
Countries
Canada
Outcome results
None listed