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 August 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01515748
First received: January 10, 2012
Last updated: August 14, 2014
Last verified: August 2014

January 10, 2012
August 14, 2014
January 2012
July 2018   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01515748 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Drug: DOCETAXEL (XRP6976)
    Pharmaceutical form:solution for infusion Route of administration: intravenous
  • Drug: OXALIPLATIN (SR96669)
    Pharmaceutical form:solution for infusion Route of administration: intravenous
  • Drug: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + CDHP (Gemeracil) + Oxo (Oteracil)
    Pharmaceutical form:Tablet Route of administration: Oral
  • 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
    Interventions:
    • Drug: DOCETAXEL (XRP6976)
    • Drug: OXALIPLATIN (SR96669)
  • surgery + adjuvant chemotherapy
    surgery + S-1 80 mg/m²/day for 1yr
    Intervention: Drug: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + CDHP (Gemeracil) + Oxo (Oteracil)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
640
July 2018
July 2018   (final data collection date for primary outcome measure)

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.

Both
20 Years to 75 Years
No
Contact: For site information, send an email with site number to Contact-Us@sanofi-aventis.com
Korea, Republic of
 
NCT01515748
DOCET_R_05153
Yes
Sanofi
Sanofi
Not Provided
Principal Investigator: Yoon-Koo KANG, MD, PhD Asan Medical Center
Sanofi
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP