Colorectal NeoplasmsPhase 3NCT00156975
Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases
A Phase 3 study testing Capecitabine and Oxaliplatin in people with Colorectal Neoplasms and Liver Metastases, run by Arbeitsgruppe Lebermetastasen und Tumoren at 3 sites in Germany.
Trial summary
Primary endpoint of the study is to prove the superiority of an adjuvant therapy with oxaliplatin/ capecitabine until the first occurrence of appearance of a tumour. Occurrences in the meaning of this study are the appearance of a relapse of the tumour, of metastases, of a second tumour or death of any reason. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Liver Metastases
- What is being tested?
- Capecitabine and Oxaliplatin
- How many people
- 384 participants
- Where
- 3 sitesGermany
- Study dates
- Nov 2004to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients after R0-resection of colorectal liver metastases
- age: >= 18 years
- Karnofsky-Index >= 70%
- neutrophiles >1,5 x10e9/l, thrombocytes 100 x10e9/l
- adequate contraception for male and female patients
- oral and written informed consent (GCP)
Who cannot join
- other prior malignancies, except treated in situ-carcinoma of cervix or tumours of skin without indication to a melanoma (or 10 years tumourfree)
- other participation in clinical trials within 30 days before randomization
- previous chemotherapy (except adjuvant chemotherapy with an interval of >= 6 months)
- creatinine clearance <50 ml/min
- hepatic insufficiency (ALAT, ASAT, Bilirubin, AP >5 x upper limit)
- peripheral neuropathy > CTC grade 1
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- uncontrolled cardiac insufficiency or angina pectoris
- active infections
- severe neurological or psychiatric illness
- breast-feeding or pregnant women
- incapacity to take part in regular visits
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik
Dresden, Saxony, 011307
Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II
Essen, 45122
Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität
Frankfurt am Main, 60590
About this study
Official title: Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study
Primary endpoint of the study is to prove the superiority of an adjuvant therapy with oxaliplatin/ capecitabine until the first occurrence of appearance of a tumour. Occurrences in the meaning of this study are the appearance of a relapse of the tumour, of metastases, of a second tumour or death of any reason.
Read the detailed description
Prospective, randomized, multi-centre, open phase III study with two parallel groups of patients according to the eligibility criteria. The times in both hierarchical classified endpoints will be measured as times from randomization.
Patients with macroscopic complete resection of colorectal liver metastases will be randomized in:
Arm A: post-operative adjuvant therapy with Capecitabine/ Oxaliplatin over 6 months and follow-up
or
Arm B: follow-up
Randomization: stratification after Scores of Fong et al:
- number of metastases (1 vs. >=1)
- maximal diameter of the metastasis (<= 5cm vs. > 5cm)
- disease free interval (>= 12 months vs. > 12 months)
- CEA (<= 200ng/l vs. >200 ng/l) in the strata 0-1, 2 and >= 3,
- Conditions
- Colorectal Neoplasms, Liver Metastases
- Being tested
- Capecitabine, Oxaliplatin
- Keywords
- Oxaliplatin, Capecitabine, Chemotherapy, Resection, Liver metastases, Liver resection, Adjuvant
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
OxaliplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes:
Disease free survival
Secondary outcomes (1)
Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- 384 participants
Sponsor and investigators
- Lead sponsor
- Arbeitsgruppe Lebermetastasen und Tumoren
- Sponsor type
- University, hospital or other
- Investigators
- Wolf O. Bechstein, Prof. Dr., Principal investigator, Arbeitsgruppe Lebermetastasen und Tumoren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156975
- Sponsor's protocol ID
- ADHOC
- Status last verified
- Apr 2007
- First submitted
- 9 Sep 2005
- Last updated
- 25 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemotherapy With Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases- Randomized Phase III Study
- ClinicalTrials.gov ID
- NCT00156975
- Acronym / sponsor ID
- ADHOC
- Conditions
- Colorectal Neoplasms, Liver Metastases
- Keywords
- Oxaliplatin, Capecitabine, Chemotherapy, Resection, Liver metastases, Liver resection, Adjuvant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants
- Lead sponsor
- Arbeitsgruppe Lebermetastasen und TumorenUniversity, hospital or other
- Study start
- Nov 2004
- First posted
- 12 Sep 2005 (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.
Primary endpoint of the study is to prove the superiority of an adjuvant therapy with oxaliplatin/ capecitabine until the first occurrence of appearance of a tumour. Occurrences in the meaning of this study are the appearance of a relapse of the tumour, of metastases, of a second tumour or death of any reason.
Detailed description
Prospective, randomized, multi-centre, open phase III study with two parallel groups of patients according to the eligibility criteria. The times in both hierarchical classified endpoints will be measured as times from randomization.
Patients with macroscopic complete resection of colorectal liver metastases will be randomized in:
Arm A: post-operative adjuvant therapy with Capecitabine/ Oxaliplatin over 6 months and follow-up
or
Arm B: follow-up
Randomization: stratification after Scores of Fong et al:
- number of metastases (1 vs. >=1)
- maximal diameter of the metastasis (<= 5cm vs. > 5cm)
- disease free interval (>= 12 months vs. > 12 months)
- CEA (<= 200ng/l vs. >200 ng/l) in the strata 0-1, 2 and >= 3,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients after R0-resection of colorectal liver metastases
- age: >= 18 years
- Karnofsky-Index >= 70%
- neutrophiles >1,5 x10e9/l, thrombocytes 100 x10e9/l
- adequate contraception for male and female patients
Key exclusion criteria (11 listed)
- other prior malignancies, except treated in situ-carcinoma of cervix or tumours of skin without indication to a melanoma (or 10 years tumourfree)
- other participation in clinical trials within 30 days before randomization
- previous chemotherapy (except adjuvant chemotherapy with an interval of >= 6 months)
- creatinine clearance <50 ml/min
- hepatic insufficiency (ALAT, ASAT, Bilirubin, AP >5 x upper limit)
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 | Drug | – |
| Oxaliplatin | Drug | – |
Primary outcome
Primary outcomes:
Disease free survival
1 secondary outcome
Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2009.
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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.
Wolf O. Bechstein, Prof. Dr. principal investigator
Arbeitsgruppe Lebermetastasen und Tumoren
3 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 Capecitabine and Oxaliplatin in people with Colorectal Neoplasms and Liver Metastases, run by Arbeitsgruppe Lebermetastasen und Tumoren at 3 sites in Germany.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 25 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
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?
Primary outcomes:. 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 25 Dec 2009.