Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00816543
First received: December 31, 2008
Last updated: December 17, 2012
Last verified: December 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: DOCETAXEL Drug: S-1 Drug: OXALIPLATIN |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- R0 resection rate [ Time Frame: At the end of the treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Physical examination [ Time Frame: Every 3 months during the study period ] [ Designated as safety issue: No ]
- Chest X-Ray [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
- Computed Tomography scan of the abdomen [ Time Frame: Every 6 months during the study period ] [ Designated as safety issue: No ]
- Gastrofiberscopy [ Time Frame: Every 1 year from the completion of the treatment for 2 years ] [ Designated as safety issue: No ]
- Laboratory analysis [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
| Enrollment: | 41 |
| Study Start Date: | December 2008 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00816543 History of Changes |
| Other Study ID Numbers: | DOCET_R_03761 |
| Study First Received: | December 31, 2008 |
| Last Updated: | December 17, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Oxaliplatin Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013