Stomach NeoplasmsPhase 2NEOTAXNCT00343239
Docetaxel in Locally Advanced Gastric Adenocarcinoma
A Phase 2 study testing Docetaxel, Cisplatin and Fluorouracil in people with Stomach Neoplasms, run by Sanofi at 1 site in Turkey (Türkiye).
Trial summary
Study objectives: To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Docetaxel, Cisplatin and Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2006to Mar 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven gastric adenocarcinoma diagnosis
- Selected Stage IIB (T3N0M0), Stage IIIA (T2aN2M0, T2bN2M0, T3N1M0, T4N0M0), Stage IIIB (T3N2M0) and selected Stage IV (all T4 , NM0, all TN3M0's). Clinical staging performed with endoscopic ultrasound and CT. Laparotomy or laparoscopy is preferred to determine resectability and peritoneal involvement.
- ECOG performance status between 0 and 2
- Acceptable hematological profile :
- WBC (White Blood Cell) count ≥4000/mm3
- Platelet count ≥100 000 mm3
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- Hemoglobin ≥9 g/100 mL (if lower, may be included following transfusion)
- Adequate renal function
- Serum creatinine <1.2 mg/dl or calculated creatinine clearance in 24-hours urine >60 mL/min.
- Adequate hepatic function
- Bilirubin < UNL
- Transaminases (ALT, AST) <2.5 x UNL
- Alcaline phosphatase <2.5 x UNL
- Adequate pulmonary function
- Adequate cardiac function
- No prior chemotherapy for gastric cancer
Who cannot join
- Other histological types of gastric cancer (leiomyosarcoma, lymphoma) than adenocarcinoma
- Pregnant or lactating patients
- Patients with brain, bone or other metastases; peritoneal involvement
- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus, serious neuropathy), history of myocardial infarction within 6 months prior to study entry
- Previous or other current malignancies, with the exception of carcinoma of the cervix uteri or breast cancer or basal cell skin cancer and a disease-free period shorter than 5 years
- Active infection and other serious disease
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- Any other experimental drugs within a 4-week period prior to the study
- Contraindications for the use of any study drug (e.g. history of hypersensitivity to the contents of the study drugs)
- 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: Docetaxel, Cisplatin and Fluorouracil Combination in the Neoadjuvant Treatment of Locally Advanced Gastric Adenocarcinoma : Phase II Clinical Study
Study objectives:
To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma.
- Conditions
- Stomach Neoplasms
- Being tested
- Docetaxel, Cisplatin, Fluorouracil
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Formulation: infusion solution
Route of administration: IV infusion on the first day of each 21-day cycle
Dose regimen: 75 mg/m2
CisplatinDrug
Formulation: infusion solution
Route of administration: IV infusion on the first day of each 21-day cycle
Dose regimen: 75 mg/m2
FluorouracilDrug
Formulation: infusion solution
Route of administration: IV infusion on the first day of each 21-day cycle
Dose regimen: 750 mg/m2/day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel/Cisplatin/Fluorouracil (DCF) | Experimental | DCF combination for three 21-day cycles unless a disease progression is observed at the tumor assessment scheduled after the second cycle or due to patient intolerability Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination.
Measured: 3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edibe Taylan, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343239
- Sponsor's protocol ID
- DOCET_L_00072
- Acronym
- NEOTAX
- Status last verified
- Nov 2014
- First submitted
- 21 Jun 2006
- Last updated
- 4 Nov 2014
- Results posted
- No
Publications
Ozdemir N, Abali H, Vural M, Yalcin S, Oksuzoglu B, Civelek B, Oguz D, Bostanci B, Yalcin B, Zengin N. Docetaxel, cisplatin, and fluorouracil combination in neoadjuvant setting in the treatment of locally advanced gastric adenocarcinoma: Phase II NEOTAX study. Cancer Chemother Pharmacol. 2014 Dec;74(6):1139-47. doi: 10.1007/s00280-014-2586-6. Epub 2014 Sep 19.
PubMed 25234436
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel, Cisplatin and Fluorouracil Combination in the Neoadjuvant Treatment of Locally Advanced Gastric Adenocarcinoma : Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT00343239
- Acronym / sponsor ID
- NEOTAX / DOCET_L_00072
- Conditions
- Stomach Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Jun 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.
Study objectives:
To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel/Cisplatin/Fluorouracil (DCF) | Experimental | Drug: Docetaxel, Drug: Cisplatin, Drug: FluorouracilDCF combination for three 21-day cycles unless a disease progression is observed at the tumor assessment scheduled after the second cycle or due to patient intolerability |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically proven gastric adenocarcinoma diagnosis
- Selected Stage IIB (T3N0M0), Stage IIIA (T2aN2M0, T2bN2M0, T3N1M0, T4N0M0), Stage IIIB (T3N2M0) and selected Stage IV (all T4 , NM0, all TN3M0's). Clinical staging performed with endoscopic ultrasound and CT. Laparotomy or laparoscopy is preferred to determine resectability and peritoneal involvement.
- ECOG performance status between 0 and 2
- Acceptable hematological profile :
- Adequate renal function
Key exclusion criteria (9 listed)
- Other histological types of gastric cancer (leiomyosarcoma, lymphoma) than adenocarcinoma
- Pregnant or lactating patients
- Patients with brain, bone or other metastases; peritoneal involvement
- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus, serious neuropathy), history of myocardial infarction within 6 months prior to study entry
- Previous or other current malignancies, with the exception of carcinoma of the cervix uteri or breast cancer or basal cell skin cancer and a disease-free period shorter than 5 years
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 |
|---|---|---|
| DocetaxelFormulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2 | Drug | Docetaxel/Cisplatin/Fluorouracil (DCF) |
| CisplatinFormulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2 | Drug | Docetaxel/Cisplatin/Fluorouracil (DCF) |
| FluorouracilFormulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 750 mg/m2/day for 5 days | Drug | Docetaxel/Cisplatin/Fluorouracil (DCF) |
Primary outcome
To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination.
Time frame: 3 cycles
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 4 Nov 2014.
- Results publication: PubMed 25234436Ozdemir N, Abali H, Vural M, Yalcin S, Oksuzoglu B, Civelek B, Oguz D, Bostanci B, Yalcin B, Zengin N. Docetaxel, cisplatin, and fluorouracil combination in neoadjuvant setting in the treatment of locally advanced gastric adenocarcinoma: Phase II NEOTAX study. Cancer Chemother Pharmacol. 2014 Dec;74(6):1139-47. doi: 10.1007/s00280-014-2586-6. Epub 2014 Sep 19.
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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.
Edibe Taylan 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 Docetaxel, Cisplatin and Fluorouracil in people with Stomach Neoplasms, run by Sanofi at 1 site in Turkey (Türkiye).
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 16 inclusion and 9 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 4 Nov 2014. 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 Turkey (Türkiye). 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?
To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination. (time frame: 3 cycles). 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 NCT00343239, which also lists 1 linked publication.
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 4 Nov 2014.