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Phase I/II Study to Investigate the Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer, Unresectable Pancreatic Cancer

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Trial Information

Phase I/II Study to Investigate the Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events

Outcome Description:

Acute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

Marie-Pierre Campeau, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre hospitalier de l'Université de Montréal (CHUM)

Authority:

Canada: Ethics Review Committee

Study ID:

CE 09.153

NCT ID:

NCT01304160

Start Date:

September 2010

Completion Date:

July 2013

Related Keywords:

  • Pancreatic Cancer
  • Unresectable Pancreatic Cancer
  • pancreatic cancer
  • stereotactic body radiotherapy
  • radiation
  • gemcitabine
  • locally advanced
  • Pancreatic Neoplasms

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