Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304160
• Other study ID #: CE 09.153
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 21, 2011
• Last updated: August 3, 2016
• Start date: September 2010
• Est. completion date: July 2016

Study information

• Verified date: August 2012
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Unresectable Pancreatic Cancer

Intervention

Radiation:
• stereotactic body radiotherapy
30Gray in 5 fractions

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	Acute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0	one year	Yes
Secondary	Quality of life	Quality of life will be evaluated with the EORTC QLQ-C30 questionnaire	3 monthly	No
Secondary	Local control	Local control will be assessed with 3 monthly CT-scans of the abdomen. RECIST criteria will be used to evaluate local control.	3 monthly	No
Secondary	overall survival		one and two year	No