Status:
COMPLETED
Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A standard treatment for pancreatic cancer is radiation therapy plus chemotherapy after surgery. Radiation therapy and chemotherapy are commonly given for up to six weeks. Previous research has sugges...
Detailed Description
* Not everyone who participates in this research study will receive the same schedule of radiation therapy. The schedule of radiation therapy will depend on the number of participants enrolled on the ...
Eligibility Criteria
Inclusion
- Cytologic of histologic proof of pancreatic ductal carcinoma
- No evidence of metastatic disease
- 18 years of age or older
- ECOG Performance Status of 0 or 1 - Lab values as outlined in the protocol
Exclusion
- Tumors in the body or tail of the pancreas
- Hepatic or peritoneal metastases detected by imaging or laparoscopy prior to chemoradiation
- Serious concomitant systemic disorders incompatible with the study, such as significant cardiac or pulmonary morbidity, ongoing infection as manifested by fever
- Pregnant or lactating women
- Life expectancy of \< 3 months
- Serious, uncontrolled, concurrent infection (s)
- Prior chemotherapy or radiation for treatment of the patient's pancreatic tumor
- Clinically significant cardiac disease or myocardial infarction within the last 12 months
- Other serious uncontrolled medical condition that the investigator feels might compromise study participation
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- Known, existing uncontrolled coagulopathy
- Any prior fluoropyrimidine therapy
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to a 5-fluorouracil or known DPD deficiency
- Participation in any investigational drug study within 4 weeks preceding the start of the study
- History of uncontrolled seizures, central nervous system disorders or psychiatric disability
- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
- Patients on cimetidine
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00438256
Start Date
December 1 2007
End Date
December 1 2017
Last Update
January 23 2019
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215