Esophageal NeoplasmsPhase 2NCT00259402
Oxaliplatin in Esophagus Cancer (Advanced) 1st Line
A Phase 2 study testing Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) in people with Esophageal Neoplasms, run by Sanofi at 1 site in Spain.
Trial summary
To determine the activity and efficacy of the schema specified as dose regimen To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2000to Oct 2008
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG 0-1
- Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease;
- No previous treatment with chemotherapy or radiotherapy
- Measurable lesion (uni or bidimensional)
Who cannot join
- Creatinin clearance <50 mL/min
- Total bilirubin >1.5*ULN (Upper Limit of Normal)
- AST/ALT > 2.5*ULN
- Total White Blood Cell <1.500.000/mL
- Platelet count <100.000.000/mL
- symptomatic sensitive peripheral neuropathy
- pregnant or breast-feeding women
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients
- To determine the activity and efficacy of the schema specified as dose regimen
- To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU
- Conditions
- Esophageal Neoplasms
- Being tested
- Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)Drug
OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin | Experimental | Not described Receives: Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoints include tumor response, progression free and overall survival.
Measured: Throughout the whole study
Secondary outcomes (1)
Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.
Measured: Throughout the whole study duration
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 startFeb 2000
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT00259402
- Sponsor's protocol ID
- EFC_7127
- 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 II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients
- ClinicalTrials.gov ID
- NCT00259402
- Acronym / sponsor ID
- EFC_7127
- Conditions
- Esophageal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (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.
- To determine the activity and efficacy of the schema specified as dose regimen
- To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin | Experimental | Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ECOG 0-1
- Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease;
- No previous treatment with chemotherapy or radiotherapy
- Measurable lesion (uni or bidimensional)
Key exclusion criteria (8 listed)
- Creatinin clearance <50 mL/min
- Total bilirubin >1.5*ULN (Upper Limit of Normal)
- AST/ALT > 2.5*ULN
- Total White Blood Cell <1.500.000/mL
- Platelet count <100.000.000/mL
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 + cisplatin + 5-Fluorouracil (5-FU)OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy | Drug | Oxaliplatin |
Primary outcome
Efficacy endpoints include tumor response, progression free and overall survival.
Time frame: Throughout the whole study
1 secondary outcome
Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.
Time frame: Throughout the whole study duration
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 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 2 study testing Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) in people with Esophageal 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 8 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 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 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?
Efficacy endpoints include tumor response, progression free and overall survival. (time frame: Throughout the whole study). 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.