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Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00816543
First received: December 31, 2008
Last updated: December 17, 2012
Last verified: December 2012

December 31, 2008
December 17, 2012
December 2008
May 2012   (final data collection date for primary outcome measure)
R0 resection rate [ Time Frame: At the end of the treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00816543 on ClinicalTrials.gov Archive Site
  • Physical examination [ Time Frame: Every 3 months during the study period ] [ Designated as safety issue: No ]
  • Chest X-Ray [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Computed Tomography scan of the abdomen [ Time Frame: Every 6 months during the study period ] [ Designated as safety issue: No ]
  • Gastrofiberscopy [ Time Frame: Every 1 year from the completion of the treatment for 2 years ] [ Designated as safety issue: No ]
  • Laboratory analysis [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Drug: DOCETAXEL
    50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.
  • Drug: S-1
    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.
  • Drug: OXALIPLATIN
    100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.
Experimental: 1
3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.
Interventions:
  • Drug: DOCETAXEL
  • Drug: S-1
  • Drug: OXALIPLATIN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
May 2012
May 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00816543
DOCET_R_03761
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Faith Fung Sanofi
Sanofi
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP