Rectum CancerPhase 2NCT00964457
Treatment of Patients With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before, Under and After Radiation and With Adding Cetuximab to K-RAS Wild-type Patients
A Phase 2 study testing cetuximab in people with Rectum Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- advanced rectum cancer
Who cannot join
- prior radiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Patient With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before Under and After Radiation and With Adding Cetuximab to K_RAS Wild-type Patients.
response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer
Read the detailed description
Dynamic MRI will be used to monitor the effect of the treatment and will be compared to pathologic results.
- Conditions
- Rectum Cancer
- Being tested
- cetuximab
- Keywords
- cetuximab, rectum cancer, radiation, MRI
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabDrug
cetuximab 500mg per meter square every second week
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine, oxaliplatin | Active comparator | Not described Receives: Drug: cetuximab |
| capecitabine, oxaliplatin and cetuximab | Active comparator | capecitabine, oxaliplatin ane cetuximab Receives: Drug: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2012 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964457
- Sponsor's protocol ID
- GI0905
- Status last verified
- Aug 2009
- First submitted
- 21 Aug 2009
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patient With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before Under and After Radiation and With Adding Cetuximab to K_RAS Wild-type Patients.
- ClinicalTrials.gov ID
- NCT00964457
- Acronym / sponsor ID
- GI0905
- Conditions
- Rectum Cancer
- Keywords
- cetuximab, rectum cancer, radiation, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 25 Aug 2009 (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.
response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer
Detailed description
Dynamic MRI will be used to monitor the effect of the treatment and will be compared to pathologic results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine, oxaliplatin | Active comparator | Drug: cetuximab |
| capecitabine, oxaliplatin and cetuximab | Active comparator | Drug: cetuximabcapecitabine, oxaliplatin ane cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- advanced rectum cancer
Key exclusion criteria (1 listed)
- prior radiation
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 |
|---|---|---|
| cetuximabcetuximab 500mg per meter square every second week | Drug | Capecitabine, oxaliplatin, capecitabine, oxaliplatin and cetuximab |
Primary outcome
response rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cetuximab in people with Rectum Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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 1 inclusion and 1 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 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
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?
response rate (time frame: 3 years). 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 Aug 2009; AzTrials last refreshed its copy on 8 Nov 2026.