Pancreatic CancerPhase 1/2NCT00593866
Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer
A Phase 1/2 study testing INTENSITY MODULATED RADIOTHERAPY and Gemcitabine in people with Pancreatic Cancer, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- INTENSITY MODULATED RADIOTHERAPY and Gemcitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2006to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Of Michigan
Ann Arbor, Michigan, 48109-5010
Rush University Medical Center
Chicago, Illinois, 60612-3833
About this study
Official title: 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.
- Conditions
- Pancreatic Cancer
- Being tested
- INTENSITY MODULATED RADIOTHERAPY, Gemcitabine
- Keywords
- Patients who have confirmed cancer arising from the pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTENSITY MODULATED RADIOTHERAPYRadiation
Also called 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
Five fractions weekly, fraction size determined by dose level
GemcitabineDrug
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
| Study group | Role | What they receive |
|---|---|---|
| Radiation Dose Escalation with Gemcitabine | Experimental | 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 Receives: Radiation: INTENSITY MODULATED RADIOTHERAPY; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13 weeks post radiation
Secondary outcomes (1)
The Percentage of Participants Free From Local Progression at 2 Years
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJun 2006
- Primary completionMay 2012
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center
- Responsible party
- Sponsor
- Investigators
- Mark Zalupski, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593866
- Sponsor's protocol ID
- UMCC 2006.018
- Other IDs
- IRB #HUM3315
- Status last verified
- Aug 2015
- First submitted
- 2 Jan 2008
- Last updated
- 11 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00593866
- Acronym / sponsor ID
- UMCC 2006.018
- Conditions
- Pancreatic Cancer
- Keywords
- Patients who have confirmed cancer arising from the pancreas
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Rush University Medical Center
- Study start
- Jun 2006
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 27 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Dose Escalation with Gemcitabine | Experimental | Radiation: INTENSITY MODULATED RADIOTHERAPY, Drug: GemcitabineINTENSITY 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTENSITY MODULATED RADIOTHERAPYAlso: 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 50.4Five fractions weekly, fraction size determined by dose level | Radiation | Radiation Dose Escalation with Gemcitabine |
| Gemcitabine1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment | Drug | Radiation Dose Escalation with Gemcitabine |
Primary outcome
The Maximum Tolerated Radiation Dose
Time frame: 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.
1 secondary outcome
The Percentage of Participants Free From Local Progression at 2 Years
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Zalupski, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INTENSITY MODULATED RADIOTHERAPY and Gemcitabine in people with Pancreatic Cancer, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Maximum Tolerated Radiation Dose (time frame: 13 weeks post radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2015.