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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


Phase 3
20 Years
75 Years
Open (Enrolling)
Both
Gastric Cancer

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

up to 3 years

Safety Issue:

No

Principal Investigator

Yoon-Koo KANG, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

DOCET_R_05153

NCT ID:

NCT01515748

Start Date:

January 2012

Completion Date:

December 2017

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

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