Extrahepatic Bile Duct CancerPhase 2NCT00030511
Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer
A Phase 2 study testing fluorouracil, conventional surgery and radiation therapy in people with Extrahepatic Bile Duct Cancer and Liver Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 6 sites in 3 countries.
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. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extrahepatic Bile Duct Cancer, Liver Cancer
- What is being tested?
- fluorouracil, conventional surgery and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 6 sitesin 3 countries
- Study dates
- Oct 2001to Jul 2003
- 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 confirmed primary or recurrent biliary duct carcinoma from the proximal, middle, or distal bile ducts
- Measurable or evaluable disease that is considered resectable
- No distant metastases
- No non-contiguous liver metastases
- Resectable extension into adjacent liver allowed
- No metastasis to peritoneal cavity
- No Bismuth type 4 lesion or metastasis to celiac axis or para-aortic lymph nodes
- No tumor encasement of portal vein or hepatic artery
- No gross ascites
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- No cirrhosis
- No active cholangitis
- No fever or signs of infection in biliary drainage system
- Measurement of C-reactive protein optimal
- Bilirubin less than 3 mg/dL
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Other:
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for 3 months after study
- No weight loss greater than 20% ideal body weight
- No active duodenal or gastric ulcers
- No other prior or concurrent primary malignancy except adequately treated carcinoma in situ of the cervix or basal cell carcinoma
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
France3 sites
Centre Hospital Regional Universitaire de Limoges
Limoges, 87042
Hopital Cochin
Paris, 75674
Hopital Paul Brousse
Villejuif, 94804
Belgium2 sites
Hopital de Jolimont
Haine-Saint-Paul, 7100
Les Cliniques Saint-Joseph ASBL
Liège, B 4000
United States1 site
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract 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. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with fluorouracil before surgery in treating patients who have primary or recurrent bile duct cancer.
Read the detailed description
OBJECTIVES:
- Determine the pathologic response rate in patients with primary or recurrent biliary duct carcinoma treated with neoadjuvant radiotherapy and fluorouracil followed by surgical resection.
- Determine the tumor response, morbidity, failure patterns (locoregional vs distant), and survival in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive fluorouracil IV over 12 hours each day radiotherapy is administered. Four to six weeks after completion of chemoradiotherapy, patients undergo surgical resection. Patients with residual disease after resection may undergo boost radiotherapy.
Patients are followed every 12 weeks until disease progression and then every 16 weeks after disease progression.
PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 2.5 years.
- Conditions
- Extrahepatic Bile Duct Cancer, Liver Cancer
- Being tested
- fluorouracil, conventional surgery, radiation therapy
- Keywords
- localized resectable adult primary liver cancer, recurrent adult primary liver cancer, localized extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer
- Medical subject headings
- Bile Duct Neoplasms, Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
conventional surgeryProcedure or surgery
radiation therapyRadiation
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 startOct 2001
- Primary completionJul 2003
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrahepatic Bile Duct 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Tyvin A. Rich, MD, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030511
- Sponsor's protocol ID
- EORTC-05991
- Other IDs
- EORTC-05991
- Status last verified
- Jul 2012
- First submitted
- 14 Feb 2002
- Last updated
- 16 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT00030511
- Acronym / sponsor ID
- EORTC-05991
- Conditions
- Extrahepatic Bile Duct Cancer, Liver Cancer
- Keywords
- localized resectable adult primary liver cancer, recurrent adult primary liver cancer, localized extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Oct 2001
- 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: 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. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with fluorouracil before surgery in treating patients who have primary or recurrent bile duct cancer.
Detailed description
OBJECTIVES:
- Determine the pathologic response rate in patients with primary or recurrent biliary duct carcinoma treated with neoadjuvant radiotherapy and fluorouracil followed by surgical resection.
- Determine the tumor response, morbidity, failure patterns (locoregional vs distant), and survival in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive fluorouracil IV over 12 hours each day radiotherapy is administered. Four to six weeks after completion of chemoradiotherapy, patients undergo surgical resection. Patients with residual disease after resection may undergo boost radiotherapy.
Patients are followed every 12 weeks until disease progression and then every 16 weeks after disease progression.
PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 2.5 years.
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 |
|---|---|---|
| fluorouracil | Drug | – |
| conventional surgery | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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.
Tyvin A. Rich, MD study chair
University of Virginia
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluorouracil, conventional surgery and radiation therapy in people with Extrahepatic Bile Duct Cancer and Liver Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 6 sites in 3 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: stopped early, as of the sponsor's last update on 16 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 6 sites in France, Belgium, 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 was stopped early (reason given: low accrual). 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.
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 16 Jul 2012.