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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DOCETAXEL
S-1
OXALIPLATIN
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.

Outcomes

Primary Outcome Measures

R0 resection rate

Secondary Outcome Measures

Physical examination
Chest X-Ray
Computed Tomography scan of the abdomen
Gastrofiberscopy
Laboratory analysis

Full Information

First Posted
December 31, 2008
Last Updated
December 17, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00816543
Brief Title
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

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.
Intervention Type
Drug
Intervention Name(s)
DOCETAXEL
Intervention Description
50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
OXALIPLATIN
Intervention Description
100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.
Primary Outcome Measure Information:
Title
R0 resection rate
Time Frame
At the end of the treatment period
Secondary Outcome Measure Information:
Title
Physical examination
Time Frame
Every 3 months during the study period
Title
Chest X-Ray
Time Frame
Throughout the study period
Title
Computed Tomography scan of the abdomen
Time Frame
Every 6 months during the study period
Title
Gastrofiberscopy
Time Frame
Every 1 year from the completion of the treatment for 2 years
Title
Laboratory analysis
Time Frame
Throughout the study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faith Fung
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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