Gastric CancerPhase 2NCT00816543
Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma
A Phase 2 study testing DOCETAXEL, S-1 and OXALIPLATIN in people with Gastric Cancer, run by Sanofi at 1 site in South Korea.
Trial summary
The primary objective of this trial is: To determine whether it is feasible in locally advanced gastric or gastroesophageal cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme and also to determine what toxicities are involved. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- DOCETAXEL, S-1 and OXALIPLATIN
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed, newly diagnosed, localized gastric or gastro-esophageal adenocarcinoma, that is considered operable.
- The bulk of disease must be localized in the stomach, although the gastroesophageal junction may be involved.
- Patients with T3 or T4 carcinoma without (N0) and T2 or T3 or T4 with regional lymph node involvement assessed by EUS, no peritoneal seeding suspected on abdomen-pelvic CT or confirmed by laparoscopy.
- Performance status 0-1 in ECOG scale
- Adequate haematological function and liver and kidney function within 7 days prior to enrollment:
- Absolute neutrophil count > or = 1.5 x 10^9/L
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- Platelets > or = 100 x 10^9/L
- Haemoglobin > 10 g/dl
- Calculated creatinine clearance > or = 60 ml/min
- Total bilirubin < or = 3 x UNL
- GOT and GPT < or = 3 x UNL
Who cannot join
- Previous surgery on primary tumour
- Prior palliative surgery (open and closure, passage operation)
- Any other type of tumour (e.g. leiomyosarcoma, lymphoma) or a secondary malignancy, excepting basal cell skin carcinoma or basal cell carcinoma in situ of the cervix which have already been successfully treated
- Distant metastases (M1) including distant nodal Groups (Retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node)
- Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy
- Simultaneous therapy with other anti-tumour drugs
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- Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug resorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine, indications of resorption disorders after intestinal surgery
- Evidence of gastric outlet obstruction and /or severe tumor hemorrhage
- Other anamnestic reaction, serious illness or other medical conditions:
- Unstable, persistent cardiac disease despite medicinal treatment, myocardial infarction within 6 months before the start of the trial
- Chronic diarrhoea
- Neurological or psychological disorders including dementia and seizures
- Active, non-controllable infection or sepsis
- Actively disseminated intravascular coagulation
- Symptomatic peripheral neuropathy NCI CTC version 3.0 grade > or = 1
- Hypersensitivity to study drugs
- Patients under anticoagulant therapy with warfarin or other coumarines are excluded from participation.
- Pregnant or lactating (in case of potentially childbearing woman, pregnancy test is positive)
- Patients of child-bearing age or the potential to father a child who refuse to use adequate contraception
- Drug, substance or alcohol abuse
- 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: A Single Arm Phase II Feasibility Study of Neoadjuvant Docetaxel, Oxaliplatin and S-1 Chemotherapy in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma.
The primary objective of this trial is:
- To determine whether it is feasible in locally advanced gastric or gastroesophageal cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme and also to determine what toxicities are involved.
The secondary objective of this trial are to describe:
- The disease free survival at one and two years in that subgroup of patients that has undergone a R0 resection.
- The downstaging after 3 cycles of chemotherapy, pCR in that subgroup of patients that have undergone an R0 resection and progression-free survival and overall survival at one and two years.
- Conditions
- Gastric Cancer
- Being tested
- DOCETAXEL, S-1, OXALIPLATIN
- 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
50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.
S-1Drug
80mg/m² day 1-14 every 3 weeks for 3 cycles. The curative resection group will receive two oral doses of 40 mg/m²/day for 4 weeks, followed by 2 weeks rest, for 1 year.
OXALIPLATINDrug
100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy. Receives: Drug: DOCETAXEL; Drug: S-1; Drug: OXALIPLATIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Measured: At the end of the treatment period
Secondary outcomes (5)
Physical examination
Measured: Every 3 months during the study period
Chest X-Ray
Measured: Throughout the study period
Computed Tomography scan of the abdomen
Measured: Every 6 months during the study period
Gastrofiberscopy
Measured: Every 1 year from the completion of the treatment for 2 years
Laboratory analysis
Measured: Throughout the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Faith Fung, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816543
- Sponsor's protocol ID
- DOCET_R_03761
- Status last verified
- Dec 2012
- First submitted
- 31 Dec 2008
- Last updated
- 18 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Feasibility Study of Neoadjuvant Docetaxel, Oxaliplatin and S-1 Chemotherapy in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT00816543
- Acronym / sponsor ID
- DOCET_R_03761
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Jan 2009 (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.
The primary objective of this trial is:
- To determine whether it is feasible in locally advanced gastric or gastroesophageal cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme and also to determine what toxicities are involved.
The secondary objective of this trial are to describe:
- The disease free survival at one and two years in that subgroup of patients that has undergone a R0 resection.
- The downstaging after 3 cycles of chemotherapy, pCR in that subgroup of patients that have undergone an R0 resection and progression-free survival and overall survival at one and two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DOCETAXEL, Drug: S-1, Drug: OXALIPLATIN3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histologically confirmed, newly diagnosed, localized gastric or gastro-esophageal adenocarcinoma, that is considered operable.
- Performance status 0-1 in ECOG scale
- Adequate haematological function and liver and kidney function within 7 days prior to enrollment:
Key exclusion criteria (21 listed)
- Previous surgery on primary tumour
- Prior palliative surgery (open and closure, passage operation)
- Any other type of tumour (e.g. leiomyosarcoma, lymphoma) or a secondary malignancy, excepting basal cell skin carcinoma or basal cell carcinoma in situ of the cervix which have already been successfully treated
- Distant metastases (M1) including distant nodal Groups (Retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node)
- Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy
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 |
|---|---|---|
| DOCETAXEL50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles. | Drug | 1 |
| S-180mg/m² day 1-14 every 3 weeks for 3 cycles. The curative resection group will receive two oral doses of 40 mg/m²/day for 4 weeks, followed by 2 weeks rest, for 1 year. | Drug | 1 |
| OXALIPLATIN100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles. | Drug | 1 |
Primary outcome
R0 resection rate
Time frame: At the end of the treatment period
5 secondary outcomes
Physical examination
Time frame: Every 3 months during the study period
Chest X-Ray
Time frame: Throughout the study period
Computed Tomography scan of the abdomen
Time frame: Every 6 months during the study period
Gastrofiberscopy
Time frame: Every 1 year from the completion of the treatment for 2 years
Laboratory analysis
Time frame: Throughout the study period
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 18 Dec 2012.
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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.
Faith Fung 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, S-1 and OXALIPLATIN in people with Gastric Cancer, run by Sanofi at 1 site in South Korea.
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 11 inclusion and 21 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 18 Dec 2012. 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 South Korea. 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?
R0 resection rate (time frame: At the end of the treatment period). 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 18 Dec 2012.