Pancreatic CancerPhase 3NCT00003029
Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
A Phase 3 study testing cisplatin and fluorouracil in people with Pancreatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 19 sites in 5 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways 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?
- cisplatin and fluorouracil
- How many people
- 200 participants
- Where
- 19 sitesin 5 countries
- Study dates
- May 1997to Jul 2003
- Phase
- Phase 3
- 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:
- Histologic or cytologic proof of adenocarcinoma of the exocrine pancreas or of a metastasis associated with a radiologically identified pancreatic tumor
- Locally advanced and/or metastatic pancreatic cancer
- No measurable or evaluable target lesion is required
- No brain metastasis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 40%-100%
Hematopoietic:
- WBC at least 3,000/mm^3
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 3 times normal
Renal:
- Creatinine no greater than 1.24 mg/dL OR
- Creatinine clearance at least 80 mL/min
Cardiovascular:
- No overt cardiac disease
Other:
- No peripheral neuropathy
- No uncontrolled infectious or chronic disease
- No second primary except in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunologic therapy
Chemotherapy:
- No prior chemotherapy allowed
Endocrine therapy:
- No concurrent hormonal therapy
- At least 2 weeks since corticoid treatment
Radiotherapy:
- No prior radiotherapy allowed except as an analgesic treatment on metastasis
Surgery:
- Not specified
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
France14 sites
Centre Hospitalier de la Cote Basque
Bayonne, 64109
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, 21079
Hopital Perpetuel Secours
Levallois-Perret, 92300
Centre Hospital Regional Universitaire de Limoges
Limoges, 87042
Hopital Notre-Dame de Bon Secours
Metz, 55038
Centre Hospitalier de Montlucon
Montluçon, 03109
Clinique Hartmann
Neuilly-sur-Seine, 92200
Hopital Saint-Louis
Paris, 75475
Hopital Cochin
Paris, 75674
Centre Rene Huguenin
Saint-Cloud, 92211
Hopital Bellevue
Saint-Etienne, 42055
Clinique de l'Orangerie
Strasbourg, 67010
Hopital Paul Brousse
Villejuif, 94804
Belgium2 sites
Hopital de Jolimont
Haine-Saint-Paul, 7100
Les Cliniques Saint-Joseph ASBL
Liège, B 4000
About this study
Official title: Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas.
Read the detailed description
OBJECTIVES:
- Confirm the value of chronomodulated infusion with respect to survival in patients with locally advanced or metastatic pancreatic cancer.
- Test the value of adding cisplatin to fluorouracil in extending survival in these patients.
OUTLINE: This is a multicenter, randomized study.
The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment groups involving the use or absence of chronomodulation and cisplatin (CDDP). Treatment in each of the 4 groups is repeated for 3 courses where each course is a 5-day course of treatment.
Patients in the first group receive a chronomodulated schedule based on delivery of fluorouracil (FU). Patients in the second group receive a chronomodulated schedule of FU and CDDP. Patients in the third and fourth experimental groups receive flat schedules of FU alone or FU and CDDP, respectively. Dosages of FU are increased across the three courses whereas dosages of CDDP remain constant.
Treatment is continued until disease progression, severe toxicity, or complete remission for more than 4 months occurs.
PROJECTED ACCRUAL: 200 patients will be accrued.
- Conditions
- Pancreatic Cancer
- Being tested
- cisplatin, fluorouracil
- Keywords
- stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
fluorouracilDrug
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 startMay 1997
- Primary completionJul 2003
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.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Francis Levi, MD, PhD, Study chair, Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003029
- Sponsor's protocol ID
- EORTC-05962
- Other IDs
- EORTC-05962
- Status last verified
- Jun 2012
- First submitted
- 1 Nov 1999
- Last updated
- 2 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.
- ClinicalTrials.gov ID
- NCT00003029
- Acronym / sponsor ID
- EORTC-05962
- Conditions
- Pancreatic Cancer
- Keywords
- stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- May 1997
- Primary completion
- Jul 2003 (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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas.
Detailed description
OBJECTIVES:
- Confirm the value of chronomodulated infusion with respect to survival in patients with locally advanced or metastatic pancreatic cancer.
- Test the value of adding cisplatin to fluorouracil in extending survival in these patients.
OUTLINE: This is a multicenter, randomized study.
The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment groups involving the use or absence of chronomodulation and cisplatin (CDDP). Treatment in each of the 4 groups is repeated for 3 courses where each course is a 5-day course of treatment.
Patients in the first group receive a chronomodulated schedule based on delivery of fluorouracil (FU). Patients in the second group receive a chronomodulated schedule of FU and CDDP. Patients in the third and fourth experimental groups receive flat schedules of FU alone or FU and CDDP, respectively. Dosages of FU are increased across the three courses whereas dosages of CDDP remain constant.
Treatment is continued until disease progression, severe toxicity, or complete remission for more than 4 months occurs.
PROJECTED ACCRUAL: 200 patients will be accrued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
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 |
|---|---|---|
| cisplatin | Drug | – |
| fluorouracil | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Jul 2012.
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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.
Francis Levi, MD, PhD study chair
Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin and fluorouracil in people with Pancreatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 19 sites in 5 countries.
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 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Belgium, Israel, Italy, Portugal. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 2 Jul 2012.