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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00816543

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: DOCETAXEL Drug: S-1 Drug: OXALIPLATIN	Phase 2

Study Design

Study Type:

Interventional

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 :

Dec 1, 2008

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

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.	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.

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.

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.

Outcome Measures

Primary Outcome Measures

R0 resection rate [At the end of the treatment period]

Secondary Outcome Measures

Physical examination [Every 3 months during the study period]
Chest X-Ray [Throughout the study period]
Computed Tomography scan of the abdomen [Every 6 months during the study period]
Gastrofiberscopy [Every 1 year from the completion of the treatment for 2 years]
Laboratory analysis [Throughout the study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Seoul		Korea, Republic of

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Faith Fung, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT00816543

Other Study ID Numbers:

DOCET_R_03761

First Posted:

Jan 1, 2009

Last Update Posted:

Dec 18, 2012

Last Verified:

Dec 1, 2012

Additional relevant MeSH terms:

Adenocarcinoma

Docetaxel

Oxaliplatin

Study Results

No Results Posted as of Dec 18, 2012