This trial is active, not recruiting.

Condition pancreatic cancer
Treatments intensity modulated radiotherapy, gemcitabine
Phase phase 1/phase 2
Sponsor University of Michigan Cancer Center
Collaborator Rush University Medical Center
Start date June 2006
End date July 2013
Trial size 65 participants
Trial identifier NCT00593866, IRB #HUM3315, UMCC 2006.018


This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
INTENSITY MODULATED RADIOTHERAPY Other Names: Radiation dose escalation: Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4 BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level Biological/Vaccine: Gemcitabine Gemcitabine 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
intensity modulated radiotherapy Radiation dose escalation:
Five fractions weekly, fraction size determined by dose level
Gemcitabine 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment

Primary Outcomes

To determine the maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.
time frame: on tmt and up to 13 week post radiation follow-up/and 18m subsequent to this

Secondary Outcomes

To estimate the rates of local progression and time to local progression in patients treated with this regimen.
time frame: patients are followed indefinitely

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Is the patient 18 years of age or older. - Does the patient have histologically or cytologically proven carcinoma of the pancreas - Is the tumor unresectable or medically inoperable - Does the patient have a Zubrod performance status of ≤ 2 (appendix I). - Does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥ 100,000/mm3 - Does the patient have adequate renal function (creatinine < 2 mg/dl) and hepatic function (bilirubin < 3 mg/dl), with relief of biliary obstruction if present - Is the patient free of significant co-morbid conditions that would preclude safe administration or completion of protocol therapy - If the patient is of reproductive potential, has he or she agreed to use an effective method of contraception during treatment on this trial and for 6 months after treatment - Is the patient aware of the investigational nature of the therapy such that they can provide written informed consent Exclusion Criteria: - Does the patient have a neuroendocrine tumor of the pancreas - Does the patient have metastatic disease - Does the patient have a history of abdominal radiation therapy - Is there history of more than 1 month of therapy with single agent gemcitabine - Has the patient used any investigational agent in the month before enrollment into the study

Additional Information

Official title A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer
Principal investigator Mark Zalupski, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by University of Michigan Cancer Center.