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

NCT ID: NCT00816543

Last Updated: 2012-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-05-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

DOCETAXEL

Intervention Type: DRUG

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

S-1

Intervention Type: DRUG

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.

OXALIPLATIN

Intervention Type: DRUG

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

Interventions

DOCETAXEL

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

Intervention Type: 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.

Intervention Type: DRUG

OXALIPLATIN

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Faith Fung

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DOCET_R_03761

Identifier Type: -

Identifier Source: org_study_id