Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2006 |
| End Date: | October 2014 |
A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer
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.
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.
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
We found this trial at
2
sites
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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