Rectal CancerPhase 2NCT00297128
Preoperative Chemoradiation With Capecitabine and Cetuximab
A Phase 2 study testing Capecitabine and Cetuximab in people with Rectal Cancer, run by Austrian Breast & Colorectal Cancer Study Group at 10 sites in Austria.
Trial summary
feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Capecitabine and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 10 sitesAustria
- Study dates
- Oct 2005to Nov 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80
- bioptical confirmed adenocarcinoma of the rectum in operable T3-T4NxM0 status. In spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable
- no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma
- WHO performance status 0-2
- adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl)
- adequate hepatic function ( bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN)
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- adequate renal function (creatinin - not more than 1.5 mg/dl)
- women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test)
- willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3 month after conclusion of the study
- life expectancy of at least 3 month
- signed Informed Consent before recruitment
- exclusion of distant metastases at the time of recruitment
Who cannot join
- former radiotherapy of pelvis or abdomen
- former chemotherapy
- any other kind of malign tumor (except adequate treated skin basalioma or in situ cervical carcinoma) in the last 5 years
- general contraindication or known hypersensitivity against Cetuximab and/or Capecitabine
- Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab and Capecitabine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological or psychiatric disorders
- florid, serious infections at the time of recruitment
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- legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator
- evidence of lacking cooperation of the patient
- pregnant or breast feeding women
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Austria10 sites
State Hospital Feldkirch
Feldkirch, Vorarlberg, 6807
Medical University of Graz, Oncology
Graz, Styria, 8036
Medical University of Innsbruck, Surgery
Innsbruck, Tyrol, 6020
State Hospital Leoben
Leoben, Styria, 8700
Hospital BHS Linz, Radiooncology
Linz, Upper Austria, 4010
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 of Vienna, Radiotherapy
Vienna, State of Vienna, 1090
Klinikum Wels-Grieskirchen
Wels, Upper Austria, 4600
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, 2700
About this study
Official title: Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study
- feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
- collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status
- Conditions
- Rectal Cancer
- Being tested
- Capecitabine, Cetuximab
- Keywords
- pilot study, rectal, cancer, phase II, preoperative, chemoradiation, capecitabine, cetuximab, operable, T4, ABCSG, TAKO, R03, 96, 06
- Medical subject headings
- Rectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
CetuximabDrug
Also called Erbitux
400mg/m2 week 1, 250mg/m2 week 2-4
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Capecitabine; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
Measured: descriptive evaluation
Secondary outcomes (1)
collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status
Measured: description evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startOct 2005
- Primary completionAug 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Sponsor type
- Research network
- Collaborators
- Hoffmann-La Roche, Merck Gesellschaft mbH, Austria
- Responsible party
- Sponsor
- Investigators
- Josef Thaler, MD, Principal investigator, Austrian Breast & Colorectal Cancer Study GroupJoerg Tschmelitsch, MD, Principal investigator, Austrian Breast & Colorectal Cancer Study GroupAlexander de Vries, MD, Principal investigator, Austrian Breast & Colorectal Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297128
- Sponsor's protocol ID
- ABCSG R03 (96) / TAKO 06
- Status last verified
- Dec 2011
- First submitted
- 27 Feb 2006
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study
- ClinicalTrials.gov ID
- NCT00297128
- Acronym / sponsor ID
- ABCSG R03 (96) / TAKO 06
- Conditions
- Rectal Cancer
- Keywords
- pilot study, rectal, cancer, phase II, preoperative, chemoradiation, capecitabine, cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study GroupResearch network
- Collaborators
- Hoffmann-La Roche, Merck Gesellschaft mbH, Austria
- Study start
- Oct 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 Feb 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.
- feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
- collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Capecitabine, Drug: Cetuximab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: 18-80
- bioptical confirmed adenocarcinoma of the rectum in operable T3-T4NxM0 status. In spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable
- no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma
- WHO performance status 0-2
- adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl)
Key exclusion criteria (9 listed)
- former radiotherapy of pelvis or abdomen
- former chemotherapy
- any other kind of malign tumor (except adequate treated skin basalioma or in situ cervical carcinoma) in the last 5 years
- general contraindication or known hypersensitivity against Cetuximab and/or Capecitabine
- Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab and Capecitabine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological or psychiatric disorders
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 |
|---|---|---|
| CapecitabineAlso: Xeloda825 mg/m2 bid (on each therapy day of first 4 therapy weeks) | Drug | 1 |
| CetuximabAlso: Erbitux400mg/m2 week 1, 250mg/m2 week 2-4 | Drug | 1 |
Primary outcome
feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
Time frame: descriptive evaluation
1 secondary outcome
collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status
Time frame: description evaluation
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 30 Dec 2011.
- 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.
Josef Thaler, MD principal investigator
Austrian Breast & Colorectal Cancer Study Group
Joerg Tschmelitsch, MD principal investigator
Austrian Breast & Colorectal Cancer Study Group
Alexander de Vries, MD principal investigator
Austrian Breast & Colorectal Cancer Study Group
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine and Cetuximab in people with Rectal Cancer, run by Austrian Breast & Colorectal Cancer Study Group at 10 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 12 inclusion and 9 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 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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 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?
feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma (time frame: descriptive evaluation). 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 30 Dec 2011.