Pancreatic Cancer
Conditions
Keywords
Patients who have confirmed cancer arising from the pancreas
Brief summary
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.
Interventions
RADIATIONINTENSITY MODULATED RADIOTHERAPY
Five fractions weekly, fraction size determined by dose level
DRUGGemcitabine
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
Sponsors
Rush University Medical Center
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Maximum Tolerated Radiation Dose | 13 weeks post radiation | The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas. |
Secondary
| Measure | Time frame |
|---|---|
| The Percentage of Participants Free From Local Progression at 2 Years | 2 Years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiation Dose Escalation With Gemcitabine INTENSITY MODULATED RADIOTHERAPY
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
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Radiation Dose Escalation With Gemcitabine |
|---|---|
| Age, Continuous | 63 years |
| Baseline CA 19-9 | 102 Units Per Millilitre (U/mL) |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 30 Participants |
| Tumor Location Body/Tail | 7 participants |
| Tumor Location Head | 33 participants |
| Tumor Location Neck | 10 participants |
| Tumor Size | 3.25 centimeters (cm) |
| Tumor Volume | 47.9 Cubic Centimeter (cc) |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 50 |
| serious Total, serious adverse events | 34 / 50 |
Outcome results
Primary
The Maximum Tolerated Radiation Dose
The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.
Time frame: 13 weeks post radiation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiation Dose Escalation With Gemcitabine | The Maximum Tolerated Radiation Dose | 55 Gray (Gy) |
Secondary
The Percentage of Participants Free From Local Progression at 2 Years
Time frame: 2 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiation Dose Escalation With Gemcitabine | The Percentage of Participants Free From Local Progression at 2 Years | 59 percentage of participants |