Metastatic CancerPhase 2NCT00436267
Internal Radiation Therapy With Y-90 Microspheres, External Radiation Therapy With Tomotherapy, and Fluorouracil in Treating Patients With Newly Diagnosed or Recurrent Pancreatic Cancer and Liver Metastases That Cannot Be Removed By Surgery
A Phase 2 study testing fluorouracil, selective external radiation therapy and tomotherapy in people with Metastatic Cancer and Pancreatic Cancer, run by Goshen Health System at 1 site in United States.
Trial summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Pancreatic Cancer
- What is being tested?
- fluorouracil, selective external radiation therapy and tomotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic cancer with liver metastases
- Unresectable disease AND meets any of the following criteria:
- Newly diagnosed disease
- No prior treatment
- Received prior treatment and progressed
- Underwent prior pancreatectomy and progressed
- Liver-only disease (receives selective internal radiotherapy only)
- No known CNS metastases
- No known diffuse peritoneal metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status 80-100%
- Life expectancy > 3 months
- WBC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Bilirubin < 2 mg/dL (without extrahepatic biliary obstruction)
- Albumin > 2 g/dL
- Creatinine < 2 mg/dL
- Not pregnant
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior surgery, chemotherapy, and biologic therapy allowed
- No prior external beam radiotherapy to liver or pancreatic bed
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, 46526
About this study
Official title: Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy in different ways and giving it together with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving internal radiation therapy and external radiation therapy together with fluorouracil works in treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- Determine tumor response in patients with unresectable, newly diagnosed or recurrent pancreatic cancer and liver metastases treated with selective internal radiotherapy with yttrium Y 90 microspheres, selective external radiotherapy with tomotherapy, and fluoroucacil.
- Determine hepatic and systemic toxicity of this regimen in these patients.
Secondary
- Determine the efficacy of this regimen, in terms of time to progression and survival, in these patients.
OUTLINE: Patients receive fluorouracil IV continuously on days 1-4. Patients undergo selective internal radiotherapy with yttrium Y 90 microspheres on day 2 and selective external radiotherapy with tomotherapy on day 3.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Conditions
- Metastatic Cancer, Pancreatic Cancer
- Being tested
- fluorouracil, selective external radiation therapy, tomotherapy, yttrium Y 90 glass microspheres, yttrium Y 90 resin microspheres
- Keywords
- recurrent pancreatic cancer, stage IV pancreatic cancer, liver metastases
- Medical subject headings
- Neoplasm Metastasis, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
selective external radiation therapyRadiation
tomotherapyRadiation
yttrium Y 90 glass microspheresRadiation
yttrium Y 90 resin microspheresRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Hepatic and systemic toxicity
Secondary outcomes (2)
Time to progression
Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startNov 2006
- Primary completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goshen Health System
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth L. Pennington, MD, Study chair, Goshen Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436267
- Sponsor's protocol ID
- CDR0000530018
- Other IDs
- CCCGHS-SIRT-SERT
- Status last verified
- Nov 2009
- First submitted
- 15 Feb 2007
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00436267
- Acronym / sponsor ID
- CDR0000530018
- Conditions
- Metastatic Cancer, Pancreatic Cancer
- Keywords
- recurrent pancreatic cancer, stage IV pancreatic cancer, liver metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goshen Health SystemUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Oct 2009 (estimated)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy in different ways and giving it together with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving internal radiation therapy and external radiation therapy together with fluorouracil works in treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- Determine tumor response in patients with unresectable, newly diagnosed or recurrent pancreatic cancer and liver metastases treated with selective internal radiotherapy with yttrium Y 90 microspheres, selective external radiotherapy with tomotherapy, and fluoroucacil.
- Determine hepatic and systemic toxicity of this regimen in these patients.
Secondary
- Determine the efficacy of this regimen, in terms of time to progression and survival, in these patients.
OUTLINE: Patients receive fluorouracil IV continuously on days 1-4. Patients undergo selective internal radiotherapy with yttrium Y 90 microspheres on day 2 and selective external radiotherapy with tomotherapy on day 3.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| fluorouracil | Drug | – |
| selective external radiation therapy | Radiation | – |
| tomotherapy | Radiation | – |
| yttrium Y 90 glass microspheres | Radiation | – |
| yttrium Y 90 resin microspheres | Radiation | – |
Primary outcome
Tumor response
Hepatic and systemic toxicity
2 secondary outcomes
Time to progression
Survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Kenneth L. Pennington, MD study chair
Goshen Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluorouracil, selective external radiation therapy and tomotherapy in people with Metastatic Cancer and Pancreatic Cancer, run by Goshen Health System at 1 site 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?
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: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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?
Results are not available in the source record.
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?
Tumor response. The study lists 2 primary outcomes in all. 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 19 Dec 2013.