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Phase I/II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

Phase I/II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer

- Since we are looking for the best schedule and dose of radiation that can be
administered safely without severe or unmanageable side effects in participants with
pancreatic cancer, not everyone who participates in this research study will receive
the same dose of radiation therapy. The dose participants will get will depend upon
the number of participants enrolled in the study and how well they have tolerated their

- Radiation treatment days will begin on a weekday and continue for a total of 7 to 12
days. Capecitabine pills will begin on the morning of the first day of radiation and
be taken twice a day for 10 consecutive weekdays, while the participant is receiving

- Blood tests, vital signs and a physical exam will be performed on day 1 and day 15 and
either days 7, 8, or 9.

- Surgery will be performed 1 to 3 weeks after completion of radiation and capecitabine.

Inclusion Criteria:

- Cytologic or histologic proof of pancreatic ductal carcinoma is required prior to

- No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan
(or MRI with gadolinium and/or manganese), and all patients must be staged with a
physical exam, chest CT, and abdominal CT with intravenous contrast.

- Only potentially resectable patients are eligible. Potentially resectable is defined
as: a)no extrapancreatic disease, b)no evidence (on CT) of involvement of the celiac
axis or superior mesenteric artery, and c)no evidence (on CT or MRI) of occlusion of
the superior mesenteric vein or superior mesenteric-portal venous confluence.

- 18 years of age or older

- ECOG Performance status of 0 or 1

- Women of child bearing potential must practice adequate contraception and to refrain
from breast feeding. Female patients must have a negative pregnancy test within 7
days of treatment

- Lab values as specified in the protocol

Exclusion Criteria:

- Patients cannot have 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, or ongoing infection as manifested by

- Pregnant or lactating women

- Life expectancy < 3 months

- Serious, uncontrolled, concurrent infection(s)

- Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor

- Treatment for other cancers within the last five years, except cured non-melanoma
skin cancer and treated in situ cervical cancer

- Clinically significant cardiac disease or myocardial infarction within the last 12

- Other serious uncontrolled medical conditions that the investigator feels might
compromise study participation

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption

- Known, existing uncontrolled coagulopathy

- Unwillingness to participate or inability to comply with the protocol for the
duration of the study

- Any prior fluoropyrimidine therapy (unless given in an adjuvant setting and completed
at least 6 months earlier)

- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known
hypersensitivity to 5-fluorouracil or known DPD deficiency

- Participation in any investigational drug study within 4 weeks preceding the start of
study treatment

- History of uncontrolled seizures, central nervous system disorders or psychiatric
disability judged by the investigator to be clinically significant, precluding
informed consent, or interfering with compliance or oral drug intake

- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment,
without complete recovery

- Patients should not be on cimetidine as it can decrease the clearance of 5-FU.
Another H2-blocker or proton pump inhibitor may be substituted before study entry

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: To determine the feasibility and tolerability of radiation therapy for pancreatic cancer delivered with high dose external beam radiation in a one week accelerated schedule.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Harvey Mamon, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital/Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • radiation therapy
  • capecitabine
  • Pancreatic Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617