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Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)


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

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Trial Information

Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)


A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as
a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3
gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions
within five years. The primary endpoint is overall survival. The secondary endpoints are
progression free survival (PFS), response rate, proportion of protocol achievement,
proportion of curative resection, and adverse events.


Inclusion Criteria:



1. histologically proven adenocarcinoma of stomach

2. Borrmann type 4 or large (>=8 cm) type 3

3. no evidence of distant metastasis including liver(M0)

4. no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2)

5. no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with
laparoscopic confirmation

6. no involvement of the esophagus with > 3cm

7. an age of 20-75 years

8. an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

9. no prior chemotherapy, radiotherapy for any malignancy

10. no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)

11. no breeding from primary tumor or gastrointestinal stenosis

12. sufficient oral intake

13. adequate organ function

14. written informed consent

Exclusion Criteria:

1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ

2. pregnant or breast-feeding women

3. severe mental disease

4. systemic administration of corticosteroids, flucytosine, phenytoin or warfarin

5. other severe complications such as paralytic ileus, intestinal pneumonitis,
pulmonary fibrosis, or ischemic heart disease

6. myocardial infarction within six disease-free months

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

during the study conduct

Safety Issue:

No

Principal Investigator

Mitsuru Sasako, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hyogo College of Medicine

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG0501

NCT ID:

NCT00252161

Start Date:

November 2005

Completion Date:

April 2015

Related Keywords:

  • Gastric Neoplasm
  • Neoadjuvant Therapy
  • Stomach Neoplasms
  • Cisplatin
  • S-1(combination)
  • Neoplasms
  • Stomach Neoplasms

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