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

NCT00816543 | Completed Phase 2

• 1 other identifier: DOCET_R_03761
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  At the end of the treatment period

Secondary Outcomes (5)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

Drug: DOCETAXEL; Drug: S-1; Drug: OXALIPLATIN

Interventions

DOCETAXEL DRUG

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

1

S-1 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.

1

OXALIPLATIN DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; S 1 (combination); Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Faith Fung

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2008
• First Posted: January 1, 2009
• Study Start: December 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

KR (1)