Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Radiation: INTENSITY MODULATED RADIOTHERAPY Biological: Gemcitabine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer |
- 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 ] [ Designated as safety issue: Yes ]
- To estimate the rates of local progression and time to local progression in patients treated with this regimen. [ Time Frame: patients are followed indefinitely ] [ Designated as safety issue: Yes ]
| Enrollment: | 65 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radiation Dose Escalation with Gemcitabine
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
Biological/Vaccine: Gemcitabine Gemcitabine 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment |
Radiation: INTENSITY MODULATED RADIOTHERAPY
Five fractions weekly, fraction size determined by dose level
Other Names:
Biological: Gemcitabine
Gemcitabine 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612-3833 | |
| United States, Michigan | |
| University Of Michigan | |
| Ann Arbor, Michigan, United States, 48109-5010 | |
| Principal Investigator: | Mark Zalupski, MD | University of Michigan |
More Information
No publications provided
| Responsible Party: | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00593866 History of Changes |
| Other Study ID Numbers: | UMCC 2006.018, IRB #HUM3315 |
| Study First Received: | January 2, 2008 |
| Last Updated: | March 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan Cancer Center:
|
Patients who have confirmed cancer arising from the pancreas |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 18, 2013