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

NCT01304160 | Completed Phase 1 DMC

• 1 other identifier: CE 09.153
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Unresectable Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Quality of life

  3 monthly

• Local control

  3 monthly

• overall survival

  one and two year

Study Arms (1)

strereotactic radiotherapy, gemcitabine

EXPERIMENTAL

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

Radiation: stereotactic body radiotherapy

Interventions

stereotactic body radiotherapy RADIATION

30Gray in 5 fractions

strereotactic radiotherapy, gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Marie-Pierre Campeau, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2011
• First Posted: February 25, 2011
• Study Start: September 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 5, 2016

Record last verified: 2012-08

Locations

CA (1)