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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00816543
Recruitment Status : Completed
First Posted : January 1, 2009
Last Update Posted : December 18, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: DOCETAXEL Drug: S-1 Drug: OXALIPLATIN Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.
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.

100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.

Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: At the end of the treatment period ]

Secondary Outcome Measures :
  1. Physical examination [ Time Frame: Every 3 months during the study period ]
  2. Chest X-Ray [ Time Frame: Throughout the study period ]
  3. Computed Tomography scan of the abdomen [ Time Frame: Every 6 months during the study period ]
  4. Gastrofiberscopy [ Time Frame: Every 1 year from the completion of the treatment for 2 years ]
  5. Laboratory analysis [ Time Frame: Throughout the study period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00816543

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Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Sponsors and Collaborators
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Study Director: Faith Fung Sanofi

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Responsible Party: Sanofi Identifier: NCT00816543     History of Changes
Other Study ID Numbers: DOCET_R_03761
First Posted: January 1, 2009    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action