Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer

Completed · Phase 1/Phase 2

Conditions studied: Pancreatic Cancer

In brief

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 suggested that giving the radiation and chemotherapy for a shorter amount of time (accelerated schedule) before surgery may be better tolerated. In this research study, different schedules of proton radiation therapy will be used. Each schedule will give about the same total dose of radiation. However, the total dose will be spread out over different time periods and different numbers of sessions. The purpose is to find the shortest schedule of radiation therapy that can be given without unacceptable side effects. Proton beam radiation is being used because of its unique ability to deposit its energy directly in the tumor, resulting in less radiation to normal tissue. A new type of PET scan is also being studied to see if it can help predict the response to pre-surgery treatment.

Key facts

Study ID

NCT00438256

Run by

Massachusetts General Hospital

People needed

50

Starts

2007-12-01

Expected to finish

2017-12-01

Last updated by the study team

2019-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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