Rectal CancerPhase 2NCT00671645
Preoperative Combined RadioChemo-Molecular Target Therapy With Capecitabine, Bevacizumab, and Radiotherapy
A Phase 2 study testing capecitabine, bevacizumab 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 Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma collection of response rate (T- and M-downstaging, pathological complete remission) 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, bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 10 sitesAustria
- Study dates
- Jul 2008to 27 Feb 2009
- 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 T3NxM0 status. The tumor has to be basically surgically complete resectable (->R0).
- no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of rectum carcinoma
- WHO performance status 0-2
- adequate bone marrow reserve (granulocytes >= 3.000/µl, absolute neutrophil >= 0 1,5 x 10 9/l thrombocytes: >= 100.000/µl, haemoglobin >= 10g/dl)
- adequate hepatic function (Bilirubin: <= 1.5 x ULN, GOT und GPT <= 2.5 x ULN)
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- adequate renal function (creatinin: <= 1.25 mg/dl, creatinin-clearance: > 50 ml/min (Cockcroft and Gault formula)), proteinuria: dipstick < 2+. In case of dipstick > 2+ protein has to be measured in 24h urine and does not exceed more than 1g/24h)
- ability of intake of pills
- 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
- INR and aPTT < 1.5 ULN
- signed Informed Consent before recruitment
Who cannot join
- failure of one inclusion criteria
- former radiotherapy of pelvis or abdomen
- former chemotherapy
- any other kind of malign tumor in the last 5 years
- any other kind of tumour in the last 5 years with exception of basal cell carcinoma of skin and cervix carcinoma in situ
- general contraindication or known hypersensitivity against Bevacizumab and/or Capecitabine
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- non malign disease, if there is a contraindication with radiotherapy, or chemotherapy with Bevacizumab and Capecitabine, or a resection of rectum: uncontrolled hypertension (systolic > 150 mmHG and/or diastolic >100 mmHG) or clinical significant (e.g. active) cardiovascular disease: CVA (cardiovascular accident)/ cerebral apoplexy (< 6 months before recruitment), myocardial infarct (< 6 months before recruitment), instable angina pectoris, CHF with NYHA status II or higher, or treated serious arrhythmia, hepatic disease, significant neurologic or psychiatric disorders
- florid, serious infections at the time of recruitment
- peripheral neuropathy (NCI CTC >= Grade 1)
- 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
- major intervention within 28 days before recruitment, open wounds
- serious injuries, unhealed wounds or fractures
- patients with spinal compressions or metastases in central nervous system
- evidence of bleeding diathesis or coagulation dysfunction
- actual intake of anticoagulant or thrombolytic agents, Aspirin > 325 mg/d or within 10 days before study start)
- actual or recent (within 10 days before recruitment) therapeutic therapy with fully-dosed anticoagulants. A prophylactic treatment is permitted.
- previous thromboembolic or hemorrhagic events within the last 6 months before recruitment
- previous abdominal fistulas, GI perforation or intra-abdominal abscess within the last 6 months
- treatment with other study medication within 28 days before recruitment
- patients with malabsorption syndrome or difficulties swallowing
- pregnant or breast feeding women
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Austria10 sites
State Hospital Feldkirch, Radiotherapy
Feldkirch, Vorarlberg, 6807
Medical University Graz, Oncology
Graz, Styria, 8036
Medical University Innsbruck, Internal Medicine
Innsbruck, Tyrol, 6020
State Hospital Leoben, Surgery
Leoben, Styria, 8700
Hospital BHS Linz, Radiooncology
Linz, Upper Austria, 4010
Hospital BHB St. Veit/Glan, Surgery
Saint Veit/Glan, Carinthia, 9300
State Hospital Salzburg-Paracelsius Medical University - Oncology
Salzburg, 5020
Hospital BHB Vienna, Surgery
Vienna, 1020
Medical University Vienna, Radiotherapy
Vienna, 1090
Klinikum Wels-Grieskirchen, Coop. Group
Wels, Upper Austria, 4600
About this study
Official title: Preoperative Combined RadioChemo-MolecularTargetTherapy of the Locally Advanced Rectum Carcinoma (cT3NxM0) - a Phase II Pilot Study With Preoperative Application of Capecitabine, Bevacizumab and Radiotherapy (RTx)
- feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma
- collection of response rate (T- and M-downstaging, pathological complete remission)
Read the detailed description
Combined RadioChemotherapy:
Therapy start: within 28 days after bioptical diagnosis
Radiotherapy: 5 x 5 days 1.8 Gy radiotherapy; cummulative dose 45 Gy
Chemotherapy: Capecitabin 825mg/m² bid, on each radiation day during the first 4 weeks RCTx
Molecular Targeted Therapy: Bevacizumab 5 mg/kg body weight; day 1, 15, 29 Operation due to TME adherence to a break of min. 42 to max. 56 days after the last application of bevacizumab
- Conditions
- Rectal Cancer
- Being tested
- capecitabine, bevacizumab
- Keywords
- pilot study, rectal, carcinoma, phase II, preoperative, RadioChemo, molecular, target, therapy, T3, ABCSG, TAKO, R04, 08
- Medical subject headings
- Rectal Neoplasms, Carcinoma, Erythema Multiforme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine, bevacizumabDrug
Also called Xeloda, Avastin
Capecitabine 825 mg/m2 bid (on each therapy day of first 4 Therapy weeks) Bevacizumab 5 mg/kg weight; day 1, 15, 29
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: capecitabine, bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma
Measured: descriptive evaluation
Secondary outcomes (1)
collection of response rate (T- and M-downstaging, pathological complete remission)
Measured: descriptive evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startJul 2008
- Primary completion27 Feb 2009
- Study completion27 Feb 2009
Why it stopped: reaching of step 1 (recruitment of 8 patients) per protocol -\> risk assessment -\> termination because of occurance of toxicity Grade 3 and 4
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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Sponsor type
- Research network
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Dietmar Oefner, MD, MSc, Principal investigator, Austrian Breast & Colorectal Cancer Study GroupAlexander de Vries, MD, Principal investigator, Austrian Breast & Colorectal Cancer Study GroupWolfgang Eisterer, MD, Principal investigator, ABCSG, TAKO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671645
- Sponsor's protocol ID
- ABCSG R04/TAKO 08
- Status last verified
- Oct 2020
- First submitted
- 30 Apr 2008
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Combined RadioChemo-MolecularTargetTherapy of the Locally Advanced Rectum Carcinoma (cT3NxM0) - a Phase II Pilot Study With Preoperative Application of Capecitabine, Bevacizumab and Radiotherapy (RTx)
- ClinicalTrials.gov ID
- NCT00671645
- Acronym / sponsor ID
- ABCSG R04/TAKO 08
- Conditions
- Rectal Cancer
- Keywords
- pilot study, rectal, carcinoma, phase II, preoperative, RadioChemo, molecular, target
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: reaching of step 1 (recruitment of 8 patients) per protocol -\> risk assessment -\> termination because of occurance of toxicity Grade 3 and 4
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study GroupResearch network
- Collaborators
- Hoffmann-La Roche
- Study start
- Jul 2008
- Primary completion
- 27 Feb 2009 (actual)
- Study completion
- 27 Feb 2009 (actual)
- First posted
- 5 May 2008 (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 Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma
- collection of response rate (T- and M-downstaging, pathological complete remission)
Detailed description
Combined RadioChemotherapy:
Therapy start: within 28 days after bioptical diagnosis
Radiotherapy: 5 x 5 days 1.8 Gy radiotherapy; cummulative dose 45 Gy
Chemotherapy: Capecitabin 825mg/m² bid, on each radiation day during the first 4 weeks RCTx
Molecular Targeted Therapy: Bevacizumab 5 mg/kg body weight; day 1, 15, 29 Operation due to TME adherence to a break of min. 42 to max. 56 days after the last application of bevacizumab
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: capecitabine, bevacizumab |
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
- bioptical confirmed adenocarcinoma of the rectum in T3NxM0 status. The tumor has to be basically surgically complete resectable (->R0).
- no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of rectum carcinoma
- WHO performance status 0-2
- adequate bone marrow reserve (granulocytes >= 3.000/µl, absolute neutrophil >= 0 1,5 x 10 9/l thrombocytes: >= 100.000/µl, haemoglobin >= 10g/dl)
Key exclusion criteria (22 listed)
- failure of one inclusion criteria
- former radiotherapy of pelvis or abdomen
- former chemotherapy
- any other kind of malign tumor in the last 5 years
- any other kind of tumour in the last 5 years with exception of basal cell carcinoma of skin and cervix carcinoma in situ
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 |
|---|---|---|
| capecitabine, bevacizumabAlso: Xeloda, AvastinCapecitabine 825 mg/m2 bid (on each therapy day of first 4 Therapy weeks) Bevacizumab 5 mg/kg weight; day 1, 15, 29 | Drug | 1 |
Primary outcome
feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma
Time frame: descriptive evaluation
1 secondary outcome
collection of response rate (T- and M-downstaging, pathological complete remission)
Time frame: descriptive evaluation
Results and safety
The study was stopped early (reason given: reaching of step 1 (recruitment of 8 patients) per protocol -\> risk assessment -\> termination because of occurance of toxicity Grade 3 and 4). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- 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.
Dietmar Oefner, MD, MSc principal investigator
Austrian Breast & Colorectal Cancer Study Group
Alexander de Vries, MD principal investigator
Austrian Breast & Colorectal Cancer Study Group
Wolfgang Eisterer, MD principal investigator
ABCSG, TAKO
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, bevacizumab 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 13 inclusion and 22 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 19 Oct 2020. 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 was stopped early (reason given: reaching of step 1 (recruitment of 8 patients) per protocol -\> risk assessment -\> termination because of occurance of toxicity Grade 3 and 4). 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?
feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally 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 19 Oct 2020.