Phase II Gemcitabine + Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma
|ClinicalTrials.gov Identifier: NCT01146054|
Recruitment Status : Completed
First Posted : June 17, 2010
Results First Posted : May 15, 2017
Last Update Posted : December 19, 2017
|First Submitted Date ICMJE||June 15, 2010|
|First Posted Date ICMJE||June 17, 2010|
|Results First Submitted Date||January 10, 2017|
|Results First Posted Date||May 15, 2017|
|Last Update Posted Date||December 19, 2017|
|Start Date ICMJE||October 2009|
|Primary Completion Date||October 2013 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||To Determine the Rate of (Grade 2 or Greater) Gastrointestinal Toxicity Attributable to Gemcitabine and Fractionated SBRT at One Year. [ Time Frame: One year. ]
Grade 2 or greater late gastritis, fistula, enteritis, or ulcer or late grade 3-4 gastrointestinal toxicity at one year.
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT01146054 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Phase II Gemcitabine + Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma|
|Official Title ICMJE||Phase II Multi-Institutional Study to Evaluate the Efficacy of Gemcitabine and Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma|
|Brief Summary||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.|
Treatment on this protocol requires placement of 3-5 gold (99.9% pure, 1-5 mm length, or visicoils) fiducials for targeting purposes. The fiducials will be used as surrogates for targeting the daily tumor position during treatment. The fiducials will be placed directly into the tumor and/or periphery under endoscopic ultrasound or CT guidance. Gemcitabine prior to SBRT is optional. If given, up to 3 weeks in a 6-week period is allowable, and may be given prior to study enrollment. Administration should be on a 3-week on, 1-week off schedule, weekly at 1,000 mg/m2. Simulation should be done 5 days or more following placement of fiducials. For simulation patients will be positioned supine in an Alpha Cradle or equivalent immobilization device will be custom made for each patient. Standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT will be obtained on each patient The 4D-CT scan will be used for characterizing target motion during quiet respiration. Following simulation, patients may be treated either in a respiratory gated (Trilogy, Elekta, Novalis) or a respiratory tracking (Cyberknife) manner. The selection of which radiotherapy treatment machine to use is left to each investigator. All patients will receive 5 fractions of 6.6 Gy delivered over a five-day period. Ideally all 5 fractions should be delivered Monday through Friday, however it may be delivered over 2 weeks as long as the patient receives at least 2 fractions a week. Gemcitabine, cycles should resume up to 4 weeks following SBRT on a 3-week on, 1-week off schedule, administered weekly at 1,000 mg/m2.A detailed medical history with physical examination and quality of life assessment will be performed at 4 months, 6 months, 9 months and 1 year. A follow-up visit at 4 weeks is optional and may be done by patient's Medical Oncologist. Scans may be done at 4-6 week visit if patient is being re-evaluated for resection.
In years 2-5 the follow up interval will be every 3-6 months, as determined by the investigator at each participating institution. Follow up intervals may also be more frequent as indicated clinically. A complete blood count (CBC), comprehensive chemistry panel, tumor marker studies, and quality of life assessment will be performed at each follow-up interval until death. As permitted by each participating institution, separate samples of blood will be drawn and retained for research efforts to develop novel serum biomarkers.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Pancreatic Cancer|
|Study Arms||Experimental: SBRT and Gemzar
Before stereotactic Body Radiotherapy (SBRT) 3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F) - Positron emission tomography/Computerized tomography) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D (4 dimensional) pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles should resume/start up to 4 weeks following SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||October 2015|
|Primary Completion Date||October 2013 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
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 - Johns Hopkins University, SU - Stanford University, or MSKCC - Memorial Sloan Kettering Cancer Center).
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):
- 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
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 (follicle stimulating hormone) levels greater than 35 IU/mL (international units/milliliter). 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.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01146054|
|Other Study ID Numbers ICMJE||IRB-17073
SU-02012010-4843 ( Other Identifier: Stanford University )
PANC0007 ( Other Identifier: OnCore )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||
|Responsible Party||Albert Koong, Stanford University|
|Study Sponsor ICMJE||Stanford University|
|Collaborators ICMJE||Johns Hopkins University|
|PRS Account||Stanford University|
|Verification Date||April 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP