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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
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Device: CyberKnife based stereotactic radiotherapy
Drug: Gemcitabine
Drug: Fludeoxyglucose (18F)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Multi-Institutional Study to Evaluate the Efficacy of Gemcitabine and Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Radiotherapy and Gemzar 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146054

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Stanford University
Johns Hopkins University
Investigators
Principal Investigator: Albert Koong Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01146054     History of Changes
Other Study ID Numbers: PANC0007, SU-02012010-4843, 17073
Study First Received: June 15, 2010
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Fluorodeoxyglucose F18
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Radiopharmaceuticals
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014