Colon Cancer Stage IIPhase 3NCT00309543
Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B
A Phase 3 study testing Fluorouracil and Leucovorin in people with Colon Cancer Stage II, run by Austrian Breast & Colorectal Cancer Study Group at 18 sites in Austria.
Trial summary
This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients' survival time following surgery for colon carcinoma Stage II. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer Stage II
- What is being tested?
- Fluorouracil and Leucovorin
- How many people
- 636 participants
- Where
- 18 sitesAustria
- Study dates
- Nov 1993to not given
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically verified, operable colon carcinoma Stage II (RO, T3-4, N0, M0)
- Age: less than 80 years
- WHO Performance > 2
- Adequate bone marrow reserve, renal and hepatic functions
- Informed consent
Who cannot join
- Rectal cancer
- R1or R2 resection; carcinosis peritonei
- Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
- Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic or metabolic disease, malignant second carcinoma
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Austria18 sites
State Hospital Feldkirch
Feldkirch, Vorarlberg, 6807
Medical University of Graz, Oncology
Graz, Styria, 8036
Hospital Guessing
Guessing, Burgenland, 7540
Hospital Hainburg
Hainburg an der Donau, Lower Austria, 2410
State Hospital Kirchdorf
Kirchdorf, Upper Austria, 4560
Hospital Krems
Krems, Lower Austria, 3500
State Hospital Leoben
Leoben, Styria, 8700
Hospital Oberpullendorf
Oberpullendorf, Burgenland, 7350
Hospital BHB St. Veit/Glan, Surgery
Saint Veit A. D. Glan, Carinthia, 9330
Paracelsus Medical University Salzburg - Oncology
Salzburg, State of Salzburg, 5020
Hospital Tulln
Tulln, Lower Austria, 3430
Medical University Vienna, General Hospital
Vienna, State of Vienna, 1090
Wilheminenspital, Internal Medicin I
Vienna, State of Vienna, 1160
Hospital Waidhofen/Thaya
Waidhofen A. D. Thaya, Lower Austria, 3830
Hospital Kreuzschwestern Wels
Wels, Upper Austria, 4600
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, 2700
State Hospital Wolfsberg
Wolfsberg, Carinthia, 9400
Hospital St. Vinzenz
Zams, Tyrol, 6511
About this study
Official title: A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).
This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients' survival time following surgery for colon carcinoma Stage II.
- Conditions
- Colon Cancer Stage II
- Being tested
- Fluorouracil, Leucovorin
- Keywords
- Fluorouracil, Leucovorin, Colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorouracilDrug
LeucovorinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startNov 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IIStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 636 participants
Sponsor and investigators
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Sponsor type
- Research network
- Investigators
- Raimund Jakesz, MD, Principal investigator, Austrian Breast & Colorectal Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309543
- Sponsor's protocol ID
- ABCSG 91
- Status last verified
- Mar 2006
- First submitted
- 31 Mar 2006
- Last updated
- 3 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).
- ClinicalTrials.gov ID
- NCT00309543
- Acronym / sponsor ID
- ABCSG 91
- Conditions
- Colon Cancer Stage II
- Keywords
- Fluorouracil, Leucovorin, Colon cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 636 participants
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study GroupResearch network
- Study start
- Nov 1993
- First posted
- 3 Apr 2006 (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.
This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients' survival time following surgery for colon carcinoma Stage II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with histologically verified, operable colon carcinoma Stage II (RO, T3-4, N0, M0)
- Age: less than 80 years
- WHO Performance > 2
- Adequate bone marrow reserve, renal and hepatic functions
- Informed consent
Key exclusion criteria (4 listed)
- Rectal cancer
- R1or R2 resection; carcinosis peritonei
- Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
- Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic or metabolic disease, malignant second carcinoma
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 | – |
| Leucovorin | Drug | – |
Primary outcome
Overall survival
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 3 Apr 2006.
- Related InfoLink provided by the sponsor.
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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.
Raimund Jakesz, MD principal investigator
Austrian Breast & Colorectal Cancer Study Group
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluorouracil and Leucovorin in people with Colon Cancer Stage II, run by Austrian Breast & Colorectal Cancer Study Group at 18 sites in Austria.
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 5 inclusion and 4 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 3 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Austria. 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.
What does the primary outcome measure?
Overall survival. 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 3 Apr 2006.