Clinical trial NCT00816543: Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma
Official title: A Single Arm Phase II Feasibility Study of Neoadjuvant Docetaxel, Oxaliplatin and S-1 Chemotherapy in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-01-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion criteria:

* 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
  * 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

Exclusion Criteria

* 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
* 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.

Primary outcomes:
measure: R0 resection rate
timeFrame: At the end of the treatment period
Secondary outcomes:
measure: Physical examination
timeFrame: Every 3 months during the study period
measure: Chest X-Ray
timeFrame: Throughout the study period
measure: Computed Tomography scan of the abdomen
timeFrame: Every 6 months during the study period
measure: Gastrofiberscopy
timeFrame: Every 1 year from the completion of the treatment for 2 years
measure: Laboratory analysis
timeFrame: Throughout the study period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Faith Fung
role: STUDY_DIRECTOR
References: