Phase II Gemcitabine + Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01146054
First received: June 15, 2010
Last updated: August 19, 2013
Last verified: August 2013

June 15, 2010
August 19, 2013
October 2009
May 2014   (final data collection date for primary outcome measure)
  • To evaluate late (grade 2 or greater) gastrointestinal toxicity attributable to gemcitabine and fractionated SBRT. [ Time Frame: 12/31/2012 ] [ Designated as safety issue: Yes ]
  • To determine the local progression free survival of patients treated with gemcitabine followed by fractionated stereotactic body radiotherapy (SBRT). [ Time Frame: 12/31/2012 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01146054 on ClinicalTrials.gov Archive Site
  • Evaluate acute gastrointestinal toxicity within 3 months of treatment. [ Time Frame: 12/31/2012 ] [ Designated as safety issue: Yes ]
  • To evaluate metastasis free survival following gemcitabine and SBRT. [ Time Frame: 12/31/2012 ] [ Designated as safety issue: No ]
  • To determine the overall survival in pancreatic cancer patients treated with gemcitabine and SBRT. [ Time Frame: 12/31/2012 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase II Gemcitabine + Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma
Phase II Multi-Institutional Study to Evaluate the Efficacy of Gemcitabine and Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma

This multi-institutional trial aims to evaluate the potential benefit and side effects of adding fractionated stereotactic body radiotherapy/surgery (SBRT) before and after chemotherapy with gemcitabine for locally advanced pancreatic cancer.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Device: CyberKnife based stereotactic radiotherapy
    1. Initial orthogonal images will be obtained to confirm location of fiducial seeds.
    2. Synchrony respiratory tracking system must be used to correct for respiratory associated tumor motion. This system utilizes a series of optical diodes placed upon the patient's chest wall. While the orthogonal images are obtained, the computer generates a model correlating the position of the chest wall with the position of the internal fiducials. This model is continuously updated during treatment to correct for subtle changes in tumor location.
    3. Quality assurance will be performed as per standard practice at each participating institution.
    Other Names:
    • Trilogy(Varian, Palo Alto CA)
    • Novalis (BrainLab, Feldkirchen, Germany)
    • Synergy (Elekta AB, Stockholm, Sweden),
  • Drug: Gemcitabine
    Treatment calculated per the needs of each patient and given at the instruction of the investigator; iv
    Other Name: Gemzar
  • Drug: Fludeoxyglucose (18F)
    Treatment calculated per the needs of each patient and given at the instruction of the investigator; iv
    Other Names:
    • fluorodeoxyglucose (18F)
    • 18F-FDG
    • FDG
Experimental: Stereotactic Radiotherapy and Gemzar
Interventions:
  • Device: CyberKnife based stereotactic radiotherapy
  • Drug: Gemcitabine
  • Drug: Fludeoxyglucose (18F)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
September 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

3.1.1 Histologically confirmed adenocarcinoma of the pancreas.

3.1.2 Unresectable disease as determined by a pancreatic cancer surgeon and assessment at a GI oncology tumor board (JHU, SU, or MSKCC).

3.1.3 Up to 3 weeks of gemcitabine chemotherapy is allowed prior to SBRT.

3.1.4 Pancreatic tumors must be less than 7.5 cm in greatest axial dimension (or <1000 cc in volume) at the time of treatment planning.

3.1.5 No prior upper abdominal or liver radiation therapy.

3.1.6 No chemotherapy within 2 weeks of radiotherapy, or chemotherapy within parameters set by Investigator for each institution.

3.1.7 Age >=18 years.

3.1.8 No infections requiring systemic antibiotic treatment.

3.1.9 Karnofsky >= 70% (see Appendix III).

3.1.10 Patients must have acceptable organ and marrow function as defined below (within 1 month prior to radiotherapy):

  • leukocytes: >=3,000/uL
  • absolute neutrophil count: >=1,500uL
  • platelets: >=100,000/uL
  • total bilirubin: within 1.5X normal institutional limits
  • AST(SGOT)/ALT(SGPT): <=2.5 X institutional upper limit of normal
  • creatinine: within normal institutional limits

OR

- creatinine clearance: >=60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

3.1.11 The effects of radiation on the developing human fetus at recommended therapeutic doses can result in death of the fetus. If a woman is of child-bearing potential, a negative urine or serum pregnancy test must be demonstrated prior to treatment. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for up to 4 weeks following the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

3.1.12 Ability to understand and the willingness to sign a written informed consent document.

3.1.13 Life expectancy > 6 months

Exclusion Criteria:

3.2.1 Patients who have had prior radiotherapy to the upper abdomen.

3.2.2 Patients receiving more than 1 cycle of gemcitabine chemotherapy or other therapy prior to SBRT.

3.2.3 Children are excluded because pancreatic tumors rarely occur in this age group. Furthermore, treatment requires a great deal of patient cooperation including the ability to lie still for several hours in an isolated room.

3.2.4 No laboratory personnel will be included.

3.2.5 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

3.2.6 Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trial.

3.2.7 Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded. This applies to any woman who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum FSH levels greater than 35 mIU/mL. A negative urine or serum pregnancy test must be obtained within 72 hours prior to the start of study medication in all women of childbearing potential. Male subjects must also agree to use effective contraception for the same period as above.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01146054
PANC0007, SU-02012010-4843, 17073
Yes
Stanford University
Stanford University
Johns Hopkins University
Principal Investigator: Albert Koong Stanford University
Stanford University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP