Pancreatic CancerPhase 2NCT00002689
Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer
A Phase 2 study testing dexamethasone, fluorouracil and brachytherapy in people with Pancreatic Cancer, run by Center for Molecular Medicine at 2 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy combined with chemotherapy may kill more tumor cells. 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?
- dexamethasone, fluorouracil and brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1995to Jun 2007
- 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 proven unresectable adenocarcinoma of the pancreas limited to the head, body, or tail of the pancreas
- Diameter no greater than 5 cm
- Volume no greater than 66 mL
- No ascites (with or without tumor cells)
- No endoscopically proven tumor penetration of duodenum or stomach
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Hematopoietic:
- WBC at least 3,000/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9 g/dL (transfusion allowed)
Hepatic:
- No hepatic disease
- At least 50% uptake of technetium-sulfur colloid in normal liver if cirrhosis suspected
- No vascular occlusion of portal system
Renal:
- Creatinine no greater than 1.5 mg/dL
- BUN no greater than 25 mg/dL
Other:
- No Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- If prior chemotherapy, test dose of colloidal phosphorous P32 administered prior to attempted treatment
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to pancreas, liver, or upper gastrointestinal tract
Surgery:
- No complete surgical resection
- No splenectomy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northside Hospital Cancer Center
Atlanta, Georgia, 30342-1611
Center for Molecular Medicine
Garden City, New York, 11530
About this study
Official title: Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy combined with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.
Read the detailed description
OBJECTIVES:
- Determine the response/remission rate, survival, and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer.
OUTLINE: Patients are stratified according to prior therapy (yes vs no).
Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.
Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy. Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2.
Patients are followed monthly for 1 year then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
- Conditions
- Pancreatic Cancer
- Being tested
- dexamethasone, fluorouracil, brachytherapy, phosphorus P32, radiation therapy
- Keywords
- stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of 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.
dexamethasoneDrug
fluorouracilDrug
brachytherapyRadiation
phosphorus P32Radiation
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Duration of remission
Survival
Secondary outcomes (1)
Patterns of failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1995
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Molecular Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Stanley E. Order, MD, ScD, FACR, Study chair, Center for Molecular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002689
- Sponsor's protocol ID
- CMM-95079
- Other IDs
- CDR0000064415, CH/UMC-95079, NCI-V95-0760
- Status last verified
- Jun 2007
- First submitted
- 1 Nov 1999
- Last updated
- 18 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00002689
- Acronym / sponsor ID
- CMM-95079
- Conditions
- Pancreatic Cancer
- Keywords
- stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Center for Molecular MedicineUniversity, hospital or other
- Study start
- Sep 1995
- Study completion
- Jun 2007 (actual)
- First posted
- 27 Jan 2003 (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: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy combined with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.
Detailed description
OBJECTIVES:
- Determine the response/remission rate, survival, and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer.
OUTLINE: Patients are stratified according to prior therapy (yes vs no).
Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.
Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy. Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2.
Patients are followed monthly for 1 year then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| dexamethasone | Drug | – |
| fluorouracil | Drug | – |
| brachytherapy | Radiation | – |
| phosphorus P32 | Radiation | – |
| radiation therapy | Radiation | – |
Primary outcome
Response rate
Duration of remission
Survival
1 secondary outcome
Patterns of failure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
Stanley E. Order, MD, ScD, FACR study chair
Center for Molecular Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexamethasone, fluorouracil and brachytherapy in people with Pancreatic Cancer, run by Center for Molecular Medicine 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?
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 18 Jul 2013. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate. The study lists 3 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 18 Jul 2013.