Rectal NeoplasmsPhase 1/2NCT00403624
Evaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy in Rectal Cancer
A Phase 1/2 study testing OXALIPLATIN in people with Rectal Neoplasms, run by Sanofi.
Trial summary
Primary objective: To evaluate the rate of responses to neoadjuvant therapy + radiotherapy Secondary objective: tolerability (toxicity) and time to progression Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- OXALIPLATIN
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Nov 2005
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with measurable, histologically proven rectal cancer.
- No history of previous malignancy but adequately treated skin / cervical cancer.
- Adequate haematological, renal and liver function.
Who cannot join
- No cardiopulmonary insufficiency or coronary disease. No sensory neuropathy prior to study.
About this study
Official title: Clinical Study to Evaluate a Protocol of Oxaliplatin -UFT- Radiotherapy for the Neoadjuvant Treatment Rectal Cancer
Primary objective:
- To evaluate the rate of responses to neoadjuvant therapy + radiotherapy
Secondary objective:
- tolerability (toxicity) and time to progression
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour response
Secondary outcomes (1)
Disease free and Overall survival ; Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startJul 2001
- Primary completionNov 2005
- Study completionNov 2005
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
- 38 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- José Mª Taboada, Dr., Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403624
- Sponsor's protocol ID
- L_8128
- Status last verified
- Apr 2008
- First submitted
- 23 Nov 2006
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate a Protocol of Oxaliplatin -UFT- Radiotherapy for the Neoadjuvant Treatment Rectal Cancer
- ClinicalTrials.gov ID
- NCT00403624
- Acronym / sponsor ID
- L_8128
- Conditions
- Rectal Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 27 Nov 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.
Primary objective:
- To evaluate the rate of responses to neoadjuvant therapy + radiotherapy
Secondary objective:
- tolerability (toxicity) and time to progression
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with measurable, histologically proven rectal cancer.
- No history of previous malignancy but adequately treated skin / cervical cancer.
- Adequate haematological, renal and liver function.
Key exclusion criteria (1 listed)
- No cardiopulmonary insufficiency or coronary disease. No sensory neuropathy prior to study.
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 | – |
Primary outcome
Tumour response
1 secondary outcome
Disease free and Overall survival ; Adverse events
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 27 Aug 2010.
Related trials for Rectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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, Dr. study director
Sanofi
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.
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 3 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: finished, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Tumour response. 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 27 Aug 2010.