Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer (PRODIGY)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Sanofi
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01515748
First received: January 10, 2012
Last updated: February 18, 2015
Last verified: February 2015
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Purpose
Primary Objective:
- To compare progression free survival (PFS) in the two treatment arms
Secondary Objectives:
- Overall survival (OS)
- Postoperative stage and R0 (complete) resection rate
- Safety: Toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy1
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: DOCETAXEL (XRP6976) Drug: OXALIPLATIN (SR96669) Drug: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + CDHP (Gemeracil) + Oxo (Oteracil) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III, Open-labelled, Randomised Study of Neoadjuvant Docetaxel+Oxaliplatin+S-1 (DOS) + Surgery + Adjuvant S-1 Versus Surgery + Adjuvant S-1 in Patients With Resectable Advanced Gastric Cancer |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival (OS) [ Time Frame: Up to a maximum of 5 years ] [ Designated as safety issue: No ]
- Stage distribution in both groups assessed after surgery [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- RO resection rate [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- Number of patients with adverse events [ Time Frame: Up to a maximum of 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 640 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | July 2019 |
| Estimated Primary Completion Date: | July 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: neoadjuvant chemotherapy + surgery + adjuvant chemotherapy
Docetaxel 50 mg/m² for day 1 , Oxaliplatin 100 mg/m² for day 1, S-1 80 mg/m²/day from day 1 to day 14 + surgery + S-1 80 mg/m²/day for 1yr
|
Drug: DOCETAXEL (XRP6976)
Pharmaceutical form:solution for infusion Route of administration: intravenous
Drug: OXALIPLATIN (SR96669)
Pharmaceutical form:solution for infusion Route of administration: intravenous
|
|
surgery + adjuvant chemotherapy
surgery + S-1 80 mg/m²/day for 1yr
|
Drug: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + CDHP (Gemeracil) + Oxo (Oteracil)
Pharmaceutical form:Tablet Route of administration: Oral
|
Detailed Description:
Patients in the neoadjuvant chemotherapy arm will be treated for 3 cycles (1 cycle is 21 days) before surgery and treated for a year with TS-1 Patients in the adjuvant chemotherapy arm will get a surgery and treated for a year with TS-1. All patients will be followed during and after the study treatment until death or progression, whichever comes first.
Eligibility| Ages Eligible for Study: | 20 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-oesophageal adenocarcinoma, that is considered resectable
- Patients with clinical stage(T2-3/N(+), T4/N(+/-) :N positive means ≥8 in short axis)
- Signed informed consent
Exclusion criteria:
- Age <20 years or ≥76 years Performance status ≥2 in Eastern Cooperative Oncology Group (ECOG) scale
- The patients who have the history of other malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix which have been already successfully treated
- Previous surgery on neoplasm of stomach
- Patients who have not completely recovered from surgery
- Distant metastases (M1) to other organs including distant nodal groups (retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node). severe/unstable angina, coronary artery bypass graft, congestive heart failure, transient ischemic attack within 6 months prior to enrollment in the study
- Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy, for the currently treated gastric cancer
- Patients with active active infection or sepsis
- Intolerance of oral taking or malabsorption: lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of TS-1. 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 and indications of resorption disorders after intestinal surgery
- ≥ grade 2 severe tumour haemorrhage
- Simultaneous participation in another study, or participation in another study within 4 weeks of commencement of this study
- Pregnant or lactating patients
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515748
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515748
Contacts
| Contact: For site information, send an email with site number to | Contact-Us@sanofi-aventis.com |
Locations
| Korea, Republic of | |
| Administrative Office | Recruiting |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Sanofi
Investigators
| Principal Investigator: | Yoon-Koo KANG, MD, PhD | Asan Medical Center |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01515748 History of Changes |
| Other Study ID Numbers: | DOCET_R_05153, EFC13833 |
| Study First Received: | January 10, 2012 |
| Last Updated: | February 18, 2015 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Docetaxel Oxaliplatin |
Tegafur Antimetabolites Antimetabolites, Antineoplastic Antimitotic Agents Antineoplastic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Tubulin Modulators |
ClinicalTrials.gov processed this record on March 03, 2015