Rectal Cancer Dukes B, Dukes CPhase 3NCT00309517
Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C
A Phase 3 study testing Fluourouracil, Leucovorin and MAb 17-1A in people with Rectal Cancer Dukes B, Dukes C, run by Austrian Breast & Colorectal Cancer Study Group at 8 sites in Austria.
Trial summary
This clinical investigation examined the influence of preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer Dukes B, Dukes C
- What is being tested?
- Fluourouracil, Leucovorin and MAb 17-1A
- How many people
- 700 participants
- Where
- 8 sitesAustria
- Study dates
- Jul 1997to 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 rectal cancer Dukes B and C (Stage II, T2-4, N0-3, M0), R0
- Age: 18-80 years
- Karnofsky Performance Status > 80
- Adequate bone marrow reserve (leukocytes > 4,000, thrombocytes > 105/mm3, Hb > 10g %), renal and hepatic functions (total bilirubin and creatinine < 1.25 x ULN)
Who cannot join
- Colon cancer
- R1, R2; carcinosis peritonei
- Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
- Previous application of a murine or chimeric monoclonal antibody or antibody fragment
- Medical therapy with steroids, cyclosporin or antithymocyte globulin within 3 months pre-study
- Known hypersensitivity to animal protein
- Serious concomitant disease: HIV, chronically inflammatory intestine, diabetes mell. gravis, cerebral seizure disorder, et al.
- Pregnancy or lactation
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Austria8 sites
Hospital Baden
Baden, Lower Austria, 2500
Medical University of Graz, Oncology
Graz, Styria, 8036
Hospital Hainburg
Hainburg an der Donau, Lower Austria, 2410
General Hospital Linz
Linz, Upper Austria, 4020
Hospital BHB Linz
Linz, Upper Austria, 4020
Hospital Oberpullendorf
Oberpullendorf, Burgenland, 7350
Medical University of Vienna, General Hospital
Vienna, State of Vienna, 1090
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, 2700
About this study
Official title: A Prospectively Randomized Study on Neoadjuvant Radio-Chemotherapy in Patients With Operated Rectal Carcinoma Dukes B and C (pT2, pN1-3; pT3-4, pN0-3; M0.
This clinical investigation examined the influence of preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).
- Conditions
- Rectal Cancer Dukes B, Dukes C
- Being tested
- Fluourouracil, Leucovorin, MAb 17-1A
- Keywords
- Fluorouracil, Leucovorin, MAb 17-1A, Rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluourouracilDrug
LeucovorinDrug
MAb 17-1ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Local 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 startJul 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer Dukes B, Dukes CStudies 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
- 700 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
- NCT00309517
- Sponsor's protocol ID
- ABSCG 92
- Status last verified
- Oct 2000
- 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 Neoadjuvant Radio-Chemotherapy in Patients With Operated Rectal Carcinoma Dukes B and C (pT2, pN1-3; pT3-4, pN0-3; M0.
- ClinicalTrials.gov ID
- NCT00309517
- Acronym / sponsor ID
- ABSCG 92
- Conditions
- Rectal Cancer Dukes B, Dukes C
- Keywords
- Fluorouracil, Leucovorin, MAb 17-1A, Rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 700 participants
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study GroupResearch network
- Study start
- Jul 1997
- 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 preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).
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 (4 listed)
- Patients with histologically verified operable rectal cancer Dukes B and C (Stage II, T2-4, N0-3, M0), R0
- Age: 18-80 years
- Karnofsky Performance Status > 80
- Adequate bone marrow reserve (leukocytes > 4,000, thrombocytes > 105/mm3, Hb > 10g %), renal and hepatic functions (total bilirubin and creatinine < 1.25 x ULN)
Key exclusion criteria (8 listed)
- Colon cancer
- R1, R2; carcinosis peritonei
- Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
- Previous application of a murine or chimeric monoclonal antibody or antibody fragment
- Medical therapy with steroids, cyclosporin or antithymocyte globulin within 3 months pre-study
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 |
|---|---|---|
| Fluourouracil | Drug | – |
| Leucovorin | Drug | – |
| MAb 17-1A | Drug | – |
Primary outcome
Local recurrence-free survival
Overall survival
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2006.
- Related InfoLink provided by the sponsor.
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
8 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 Fluourouracil, Leucovorin and MAb 17-1A in people with Rectal Cancer Dukes B, Dukes C, run by Austrian Breast & Colorectal Cancer Study Group at 8 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 4 inclusion and 8 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: stopped early, 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 8 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 was stopped early. 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.
What does the primary outcome measure?
Local 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.