Rectal CancerPhase 2LARC-RRPNCT00278694
Oxaliplatin and 5-FU Based Preoperative Chemoradiation
A Phase 2 study testing Oxaliplatin, Chemoradiation and 5-FU in people with Rectal Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Oxaliplatin, Chemoradiation and 5-FU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2005to Feb 2016
- 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
Rectal cancer
Trial locations and contacts
1 site in 1 country.
About this study
Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.
Read the detailed description
Effect of treatment, safety profile and quality of life scorings.
- Conditions
- Rectal Cancer
- Being tested
- Oxaliplatin, Chemoradiation, 5-FU, Preoperative chemoradiation, Pelvic surgery
- Keywords
- Oxaliplatin, radiation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
ChemoradiationDrug
5-FUDrug
Preoperative chemoradiationRadiation
Pelvic surgeryProcedure or surgery
Neoadjuvant oxaliplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiation | Experimental | Neoadjuvant chemotherapy and chemoradiation Receives: Drug: Oxaliplatin; Drug: Chemoradiation; Drug: 5-FU; Radiation: Preoperative chemoradiation; Procedure: Pelvic surgery; Drug: Neoadjuvant oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile
Measured: 5 years
Number of patients obtaining pCR
Measured: 5 years
Secondary outcomes (1)
Clinical, radiological and molecular response to treatment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startSep 2005
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svein Dueland, Oslo University Hospital
- Investigators
- Georg Høyer, DH, Study chair, South region committee for research ethics in Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278694
- Sponsor's protocol ID
- S-05059
- Other IDs
- Eudractnr 2005-000024-16
- Acronym
- LARC-RRP
- Status last verified
- Sep 2016
- First submitted
- 16 Jan 2006
- Last updated
- 29 Sep 2016
- Results posted
- No
Publications
Abrahamsson H, Porojnicu AC, Lindstrom JC, Dueland S, Flatmark K, Hole KH, Seierstad T, Moan J, Redalen KR, Meltzer S, Ree AH. High level of circulating vitamin D during neoadjuvant therapy may lower risk of metastatic progression in high-risk rectal cancer. BMC Cancer. 2019 May 23;19(1):488. doi: 10.1186/s12885-019-5724-z.
PubMed 31122213Kalanxhi E, Hektoen HH, Meltzer S, Dueland S, Flatmark K, Ree AH. Circulating proteins in response to combined-modality therapy in rectal cancer identified by antibody array screening. BMC Cancer. 2016 Jul 26;16:536. doi: 10.1186/s12885-016-2601-x.
PubMed 27461255Hektoen HH, Flatmark K, Andersson Y, Dueland S, Redalen KR, Ree AH. Early increase in circulating carbonic anhydrase IX during neoadjuvant treatment predicts favourable outcome in locally advanced rectal cancer. BMC Cancer. 2015 Jul 24;15:543. doi: 10.1186/s12885-015-1557-6.
PubMed 26205955Ree AH, Flatmark K, Saelen MG, Folkvord S, Dueland S, Geisler J, Redalen KR. Tumor phosphatidylinositol 3-kinase signaling in therapy resistance and metastatic dissemination of rectal cancer: opportunities for signaling-adapted therapies. Crit Rev Oncol Hematol. 2015 Jul;95(1):114-24. doi: 10.1016/j.critrevonc.2015.01.003. Epub 2015 Jan 12.
PubMed 25624177
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxaliplatin and 5-FU Based Preoperative Chemoradiation
- ClinicalTrials.gov ID
- NCT00278694
- Acronym / sponsor ID
- LARC-RRP / S-05059
- Conditions
- Rectal Cancer
- Keywords
- Oxaliplatin, radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Jan 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.
Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.
Detailed description
Effect of treatment, safety profile and quality of life scorings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoradiation | Experimental | Drug: Oxaliplatin, Drug: Chemoradiation, Drug: 5-FU, Radiation: Preoperative chemoradiation, Procedure: Pelvic surgery, Drug: Neoadjuvant oxaliplatinNeoadjuvant chemotherapy and chemoradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Oxaliplatin | Drug | Chemoradiation |
| Chemoradiation | Drug | Chemoradiation |
| 5-FU | Drug | Chemoradiation |
| Preoperative chemoradiation | Radiation | Chemoradiation |
| Pelvic surgery | Procedure or surgery | Chemoradiation |
| Neoadjuvant oxaliplatin | Drug | Chemoradiation |
Primary outcome
Safety profile
Time frame: 5 years
Number of patients obtaining pCR
Time frame: 5 years
1 secondary outcome
Clinical, radiological and molecular response to treatment
Time frame: 5 years
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 29 Sep 2016.
- Derived from this study: PubMed 31122213Abrahamsson H, Porojnicu AC, Lindstrom JC, Dueland S, Flatmark K, Hole KH, Seierstad T, Moan J, Redalen KR, Meltzer S, Ree AH. High level of circulating vitamin D during neoadjuvant therapy may lower risk of metastatic progression in high-risk rectal cancer. BMC Cancer. 2019 May 23;19(1):488. doi: 10.1186/s12885-019-5724-z.
- Derived from this study: PubMed 27461255Kalanxhi E, Hektoen HH, Meltzer S, Dueland S, Flatmark K, Ree AH. Circulating proteins in response to combined-modality therapy in rectal cancer identified by antibody array screening. BMC Cancer. 2016 Jul 26;16:536. doi: 10.1186/s12885-016-2601-x.
- Derived from this study: PubMed 26205955Hektoen HH, Flatmark K, Andersson Y, Dueland S, Redalen KR, Ree AH. Early increase in circulating carbonic anhydrase IX during neoadjuvant treatment predicts favourable outcome in locally advanced rectal cancer. BMC Cancer. 2015 Jul 24;15:543. doi: 10.1186/s12885-015-1557-6.
- Derived from this study: PubMed 25624177Ree AH, Flatmark K, Saelen MG, Folkvord S, Dueland S, Geisler J, Redalen KR. Tumor phosphatidylinositol 3-kinase signaling in therapy resistance and metastatic dissemination of rectal cancer: opportunities for signaling-adapted therapies. Crit Rev Oncol Hematol. 2015 Jul;95(1):114-24. doi: 10.1016/j.critrevonc.2015.01.003. Epub 2015 Jan 12.
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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.
Georg Høyer, DH study chair
South region committee for research ethics in Norway
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 Oxaliplatin, Chemoradiation and 5-FU in people with Rectal Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Sep 2016. 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 Norway. 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?
Safety profile (time frame: 5 years). 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?
On the ClinicalTrials.gov record for NCT00278694, which also lists 4 linked publications.
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 29 Sep 2016.