Rectal CancerPhase 2NCT00297141
Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma
A Phase 2 study testing Capecitabine and Oxaliplatin in people with Rectal Cancer, run by Austrian Breast & Colorectal Cancer Study Group at 8 sites in Austria.
Trial summary
Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme 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 Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesAustria
- Study dates
- Oct 2004to Dec 2013
- 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
- Biooptical confirmed adenocarcinoma of the lower und middle rectum (lower edge of the tumor located max. 14 cm of the anal verge)
- According to MRI tumor extensions into the perirectal fat tissue (cT3)
- No former chemotherapy, radiotherapy and/or tumor resection of a rectum carcinoma
- WHO performance status 0 - 2
- Adequate bone marrow reserve (leucocytes - not more than 3.000/ml; thrombocytes - not more than 100.000/ml)
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- Adequate hepatic function (bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN)
- 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 (for example birth-control pill, loop, condom) during and at least 3 month after closure of the study
- Life expectancy of at least 3 month
- Signed written Informed Consent before recruitment
- Exclusion of distant metastases at the time of recruitment
Who cannot join
- Former radio- and/or chemotherapy
- Tumor of the upper rectum
- Any other kind of malign tumor in the last five years (except adequate treated basal cell carcinoma of the skin, or in situ cervical carcinoma)
- Peripheral Neuropathy (NCI CTC - not higher than Grade 1)
- General contraindication or hypersensitivity against Oxaliplatin and/or Capecitabine
- Any other untreated not malign diseases: Cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic diseases, significant neurological or psychiatric disorders
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- Florid, serious infection at the time of recruitment
- Legally limited capacity or evidence of a neurological or psychiatric disease, the investigator is the opinion it will constrict the patients compliance
- Evidence of lacking willingness for cooperation of the patient
- Pregnant or breast feeding women
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Austria8 sites
Medical University of Graz, Oncology
Graz, Styria, 8036
Medical University of Innsbruck, Surgery
Innsbruck, Tyrol, 6020
State Hospital Leoben, Surgery
Leoben, Styria, 8700
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 GmbH
Wels, Upper Austria, 4600
Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria, 2700
About this study
Official title: Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum
Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme
Read the detailed description
About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum will be recruited.
The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the additional administration of a chemotherapy will positively influence the effect of the therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing and downstaging (as per literature and by own experience) can be reached with an preoperative combined radiochemotherapy.
- Conditions
- Rectal Cancer
- Being tested
- Capecitabine, Oxaliplatin
- Keywords
- Preoperative, Radiochemotherapy, Newly Diagnosed, Primary Operable, Locally Advanced, Rectal Carcinoma, T3, Lower Rectum, Middle Rectum, ABCSG, TAKO, 95, 05
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda, RO 09-1978
chemotherapy oral use
OxaliplatinDrug
Also called treatment defined only by active substance, (no trade name defined; investigators choice)
chemotherapy intravenous use
| Study group | Role | What they receive |
|---|---|---|
| single arm (radiochemotherapy) | Experimental | single arm study (capecitabine, oxaliplatin) Receives: Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of T-downstaging (Reduction of the T-stadium)
surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)
Measured: at the time of final surgery
Secondary outcomes (1)
Evaluation of the toxicity grade III and IV of the therapy scheme
from Visit 1 till surgery: weekly visits (visit 1 to visit 5) followed by final examination (performed 1 to 2 weeks after visit 5) before surgery followed by hospital admission (performed 1 to 2 weeks after final examination) followed by surgery ((performed 1 to 2 weeks after hospital admission)
Measured: week 1 to max. week 10
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 2004
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Sponsor type
- Research network
- Collaborators
- Sanofi-Synthelabo, Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Dietmar Oefner, MD, Principal investigator, Austrian Breast & Colorectal Cancer Study GroupAlexander de Vries, MD, Principal investigator, Austrian Breast & Colorectal Cancer Study GroupJosef Thaler, MD, Principal investigator, Austrian Breast & Colorectal Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297141
- Sponsor's protocol ID
- ABCSG 95 / TAKO 05
- Other IDs
- Studie R02 (95), 2004-002358-72, 2004
- Status last verified
- Dec 2013
- First submitted
- 27 Feb 2006
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ofner D, Devries AF, Schaberl-Moser R, Greil R, Rabl H, Tschmelitsch J, Zitt M, Kapp KS, Fastner G, Keil F, Eisterer W, Jager R, Offner F, Gnant M, Thaler J; TAKO 05/ABCSG R-02 Trial Investigators. Preoperative oxaliplatin, capecitabine, and external beam radiotherapy in patients with newly diagnosed, primary operable, cT(3)NxM0, low rectal cancer: a phase II study. Strahlenther Onkol. 2011 Feb;187(2):100-7. doi: 10.1007/s00066-010-2182-6. Epub 2011 Jan 21.
PubMed 21267531
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum
- ClinicalTrials.gov ID
- NCT00297141
- Acronym / sponsor ID
- ABCSG 95 / TAKO 05
- Conditions
- Rectal Cancer
- Keywords
- Preoperative, Radiochemotherapy, Newly Diagnosed, Primary Operable, Locally Advanced, Rectal Carcinoma, T3, Lower Rectum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study GroupResearch network
- Collaborators
- Sanofi-Synthelabo, Hoffmann-La Roche
- Study start
- Oct 2004
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (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.
Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme
Detailed description
About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum will be recruited.
The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the additional administration of a chemotherapy will positively influence the effect of the therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing and downstaging (as per literature and by own experience) can be reached with an preoperative combined radiochemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm (radiochemotherapy) | Experimental | Drug: Capecitabine, Drug: Oxaliplatinsingle arm study (capecitabine, oxaliplatin) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: 18 - 80
- Biooptical confirmed adenocarcinoma of the lower und middle rectum (lower edge of the tumor located max. 14 cm of the anal verge)
- According to MRI tumor extensions into the perirectal fat tissue (cT3)
- No former chemotherapy, radiotherapy and/or tumor resection of a rectum carcinoma
- WHO performance status 0 - 2
Key exclusion criteria (10 listed)
- Former radio- and/or chemotherapy
- Tumor of the upper rectum
- Any other kind of malign tumor in the last five years (except adequate treated basal cell carcinoma of the skin, or in situ cervical carcinoma)
- Peripheral Neuropathy (NCI CTC - not higher than Grade 1)
- General contraindication or hypersensitivity against Oxaliplatin and/or Capecitabine
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: Xeloda, RO 09-1978chemotherapy oral use | Drug | single arm (radiochemotherapy) |
| OxaliplatinAlso: treatment defined only by active substance, (no trade name defined; investigators choice)chemotherapy intravenous use | Drug | single arm (radiochemotherapy) |
Primary outcome
Rate of T-downstaging (Reduction of the T-stadium)
Time frame: at the time of final surgery
surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)
1 secondary outcome
Evaluation of the toxicity grade III and IV of the therapy scheme
Time frame: week 1 to max. week 10
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 31 Dec 2013.
- Derived from this study: PubMed 21267531Ofner D, Devries AF, Schaberl-Moser R, Greil R, Rabl H, Tschmelitsch J, Zitt M, Kapp KS, Fastner G, Keil F, Eisterer W, Jager R, Offner F, Gnant M, Thaler J; TAKO 05/ABCSG R-02 Trial Investigators. Preoperative oxaliplatin, capecitabine, and external beam radiotherapy in patients with newly diagnosed, primary operable, cT(3)NxM0, low rectal cancer: a phase II study. Strahlenther Onkol. 2011 Feb;187(2):100-7. doi: 10.1007/s00066-010-2182-6. Epub 2011 Jan 21.
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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.
Dietmar Oefner, MD principal investigator
Austrian Breast & Colorectal Cancer Study Group
Alexander de Vries, MD principal investigator
Austrian Breast & Colorectal Cancer Study Group
Josef Thaler, 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 2 study testing Capecitabine and Oxaliplatin in people with Rectal Cancer, 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 13 inclusion and 10 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 31 Dec 2013. 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 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?
Rate of T-downstaging (Reduction of the T-stadium) (time frame: at the time of final surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297141, which also lists 1 linked publication.
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 31 Dec 2013.