Rectal NeoplasmsPhase 1/2NCT00259363
Oxaliplatin in Rectal Cancer
A Phase 1/2 study testing Oxaliplatin in people with Rectal Neoplasms, run by Sanofi at 1 site in Spain.
Trial summary
Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study Phase II: To determine the treatment efficacy according to response rates from phase I. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Oxaliplatin
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2002to Jun 2006
- Phase
- Phase 1/2
- 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
- ECOG: 0-2
- Histological proved rectal adenocarcinoma
- No chemotherapy treatment on the previous 6 months before inclusion.
- No previous pelvic radiotherapy treatment
Who cannot join
- Important Biological abnormality (renal, hepatic and/or hematological)
- Intestinal occlusion or subocclusion
- Peripheral neuropathy
- Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
- Participation in other trials on the previous 4 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer
- Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
- Phase II: To determine the treatment efficacy according to response rates from phase I.
- Conditions
- Rectal Neoplasms
- Being tested
- Oxaliplatin
- 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
oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I : Maximum Tolerated Dose & Recommended Dose
Measured: Days 1, 15, 29
Phase II : Response and resectability rate.
Measured: 6 cycles in 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startOct 2002
- Primary completionJun 2006
Why it stopped: Study cancelled because recruitment rate was too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- José Mª Taboada, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259363
- Sponsor's protocol ID
- L_8330
- Status last verified
- Dec 2009
- First submitted
- 28 Nov 2005
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer
- ClinicalTrials.gov ID
- NCT00259363
- Acronym / sponsor ID
- L_8330
- Conditions
- Rectal Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study cancelled because recruitment rate was too slow
- Enrolment
- 46 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Jun 2006 (actual)
- First posted
- 29 Nov 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.
- Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
- Phase II: To determine the treatment efficacy according to response rates from phase I.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ECOG: 0-2
- Histological proved rectal adenocarcinoma
- No chemotherapy treatment on the previous 6 months before inclusion.
- No previous pelvic radiotherapy treatment
Key exclusion criteria (5 listed)
- Important Biological abnormality (renal, hepatic and/or hematological)
- Intestinal occlusion or subocclusion
- Peripheral neuropathy
- Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
- Participation in other trials on the previous 4 months.
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 |
|---|---|---|
| Oxaliplatinoxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days | Drug | – |
Primary outcome
Phase I : Maximum Tolerated Dose & Recommended Dose
Time frame: Days 1, 15, 29
Phase II : Response and resectability rate.
Time frame: 6 cycles in 6 months
Results and safety
The study was stopped early (reason given: Study cancelled because recruitment rate was too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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.
José Mª Taboada study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oxaliplatin in people with Rectal Neoplasms, run by Sanofi at 1 site in Spain.
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 4 inclusion and 5 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 7 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 1 site in Spain. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Study cancelled because recruitment rate was too slow). 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?
Phase I : Maximum Tolerated Dose & Recommended Dose (time frame: Days 1, 15, 29). 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 7 Dec 2009.