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Phase I/II Study of Oral S-1 Plus f Oxaliplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer


Phase 1/Phase 2
20 Years
70 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

Phase I/II Study of Oral S-1 Plus f Oxaliplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer


This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of
oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of
SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence
and survival will be collected from the time of enrollment until 3 years after surgery. To
evaluate safety, data on adverse events will be collected from the time of enrollment until
1 year after surgery.


Inclusion Criteria:



- 20-70 years

- Histologically proven adenocarcinoma of the stomach

- Curative D2 lymphadenectomy resection for gastric cancer, who can start chemotherapy
be within 6 weeks after surgery

- Stage II, III (AJCC 7th edition)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- No prior chemotherapy or radiotherapy

- Adequate bone marrow, renal, and liver function

Exclusion Criteria:

- Any evidence of metastatic disease (including presence of tumor cells in the
ascites).

- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except
corticosteroids, for the currently treated gastric cancer.

- Major surgery within 4 weeks prior to study treatment start, or lack of complete
recovery from the effects of major surgery.

- Pregnant or lactating women.

- History of another malignancy within the last five years except cured basal cell
carcinoma of skin and cured carcinoma in-situ of uterine cervix.‚Ä®

- Lack of physical integrity of the upper gastrointestinal tract or those who have
malabsorption syndrome likely to influence absorption of capecitabine, or inability
to take oral medication.

- Organ allografts requiring immunosuppressive therapy.

- Serious uncontrolled intercurrent infections or other serious uncontrolled
concomitant disease.

- Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without
documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known
DPD deficiency.
Hypersensitivity to platinum compounds or any of the components of
the study medications.

- Received any investigational drug or agent/procedure, i.e. participation in another
trial, within 4 weeks before enter the trial.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3 year recurrence-free survival(RFS)

Outcome Description:

from the date of surgery until the occurrence of an event (relapse or death whichever came first)

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Lin Yang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Medical Oncology,Cancer Hospital and Institute,CAMS

Authority:

China: Food and Drug Administration

Study ID:

CH-GI-020

NCT ID:

NCT01542294

Start Date:

June 2011

Completion Date:

May 2017

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • S-1
  • oxaliplatin
  • adjuvant chemotherapy
  • Stomach Neoplasms

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