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

Primary Purpose

Pancreatic Cancer, Unresectable Pancreatic Cancer

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

stereotactic body radiotherapy

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, stereotactic body radiotherapy, radiation, gemcitabine, locally advanced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

strereotactic radiotherapy, gemcitabine

Arm Description

stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life

Quality of life will be evaluated with the EORTC QLQ-C30 questionnaire

Local control

Local control will be assessed with 3 monthly CT-scans of the abdomen. RECIST criteria will be used to evaluate local control.

overall survival

Full Information

NCT ID

NCT01304160

First Posted

February 21, 2011

Last Updated

August 3, 2016

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

1. Study Identification

Unique Protocol Identification Number

NCT01304160

Brief Title

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

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Unresectable Pancreatic Cancer

Keywords

pancreatic cancer, stereotactic body radiotherapy, radiation, gemcitabine, locally advanced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

strereotactic radiotherapy, gemcitabine

Arm Type

Experimental

Arm Description

stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiotherapy

Intervention Description

30Gray in 5 fractions

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Description

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

Time Frame

one year

Secondary Outcome Measure Information:

Title

Quality of life

Description

Quality of life will be evaluated with the EORTC QLQ-C30 questionnaire

Time Frame

3 monthly

Title

Local control

Description

Local control will be assessed with 3 monthly CT-scans of the abdomen. RECIST criteria will be used to evaluate local control.

Time Frame

3 monthly

Title

overall survival

Time Frame

one and two year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie-Pierre Campeau, MD

Organizational Affiliation

Centre hospitalier de l'Université de Montréal (CHUM)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier de l'Université de Montréal (CHUM)

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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