Colon Cancer Stage IIIPhase 3NCT00309530
Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C
A Phase 3 study testing 5-fluorouracil, levamisol, interferon in people with Colon Cancer Stage III, run by Austrian Breast & Colorectal Cancer Study Group at 16 sites in Austria.
Trial summary
This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer Stage III
- What is being tested?
- 5-fluorouracil, levamisol, interferon
- How many people
- 598 participants
- Where
- 16 sitesAustria
- Study dates
- Oct 1990to 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, curatively operated colon carcinoma Stage III (R0, T1-4, N1-3, M0)
- Age: less than 80 years
- WHO Performace Status > 2
- Adequate bone marrow reserve
- Informed consent
Who cannot join
- Rectal cancer
- R1, R2, carcinosis peritonei
- Start of chemo- or chemo-immunotherapy > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
- Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic disease, malignant second carcinoma
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Austria16 sites
State Hospital Feldkirch
Feldkirch, Vorarlberg, 6807
Medical University of Graz, Oncology
Graz, Styria, 8036
Hospital Guessing
Guessing, Burgenland, 7540
State Hospital Kirchdorf
Kirchdorf, Upper Austria, 4560
State Hospital Leoben, Surgery
Leoben, Styria, 8700
General Hospital Linz
Linz, Upper Austria, 4020
Hospital BHB Linz
Linz, Upper Austria, 4020
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
Medical University Vienna, General Hospital
Vienna, State of Vienna, 1090
Wilheminenspital, Internal Medicin I
Vienna, State of Vienna, 1160
State Hospital Voecklabruck, Internal Medicine
Vöcklabruck, Upper Austria, 4840
Hospital Kreuzschwestern Wels
Wels, Upper Austria, 4600
State Hospital Wolfsberg
Wolfsberg, Carinthia, 9400
Hospital St. Vinzenz
Zams, Tyrol, 6511
About this study
Official title: A Prospectively Randomized Phase III Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Patients With Operated Colon Carcinoma Dukes C (Stage III; T1-4, N1-30, M0).
This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III.
- Conditions
- Colon Cancer Stage III
- Being tested
- 5-fluorouracil, levamisol, interferon
- Keywords
- Fluorouracil, Levamisol, Interferon, 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.
5-fluorouracil, levamisol, interferonDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
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 startOct 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IIIStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 598 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
- NCT00309530
- Sponsor's protocol ID
- ABCSG 90
- Status last verified
- Apr 1999
- 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 Phase III Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Patients With Operated Colon Carcinoma Dukes C (Stage III; T1-4, N1-30, M0).
- ClinicalTrials.gov ID
- NCT00309530
- Acronym / sponsor ID
- ABCSG 90
- Conditions
- Colon Cancer Stage III
- Keywords
- Fluorouracil, Levamisol, Interferon, Colon cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study GroupResearch network
- Study start
- Oct 1990
- 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 effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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, curatively operated colon carcinoma Stage III (R0, T1-4, N1-3, M0)
- Age: less than 80 years
- WHO Performace Status > 2
- Adequate bone marrow reserve
- Informed consent
Key exclusion criteria (4 listed)
- Rectal cancer
- R1, R2, carcinosis peritonei
- Start of chemo- or chemo-immunotherapy > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
- Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic 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 |
|---|---|---|
| 5-fluorouracil, levamisol, interferon | Drug | – |
Primary outcome
Recurrence-free survival
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
16 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 5-fluorouracil, levamisol, interferon in people with Colon Cancer Stage III, run by Austrian Breast & Colorectal Cancer Study Group at 16 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 16 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?
Recurrence-free survival. 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 3 Apr 2006.