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Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Gastric Cancer

Thank you

Trial Information

Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer


Inclusion Criteria:



- Age 18 -75

- Histologically or cytologically proven in operable advanced gastric adenocarcinoma
(including adenocarcinoma of the gastrooesophageal junction)

- ECOG performance status ≦2

- Tumor stage Stage III

- No distant metastasis (M0)

Exclusion Criteria:

- History of hypersensitivity to fluoropyrimidines, Tegafur,Gimeracil and Oteracil
Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product

- Inadequate hematopoietic function: WBC≦4,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3

- Inadequate organ function which is defined as below:

Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal
range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 1.2 mg/dL, and Ccr > 60
ml/min (estimated by Cockcroft-Gault formulation);

- Symptomatic peripheral neuropathy

- Receiving a concomitant treatment with other fluoropyrimidines

- Pregnancy or lactation women, or women with suspected pregnancy or men unless using a
reliable and appropriate contraceptive method.

- Mental status is not fit for chemotherapy therapy presence of serious concomitant
illness which might be aggravated by study medication:

- Active cardiac disease e.g. decompensate myocardial infarction within the 6-month
period preceding entry into the study.

- History of ventricular arrhythmia or congestive heart failure.

- Significant co-morbid medical conditions, including, but not limited to, Chronic
obstructive pulmonary disease, interstitial pneumonia ,pulmonary fibrosis, heart
failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical or
paralytic ileus, or poorly controlled diabetes.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease-free survival(DFS)

Outcome Time Frame:

3 year

Safety Issue:

No

Principal Investigator

Qun Zhao, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hebei Medical University

Authority:

China: Ethics Committee

Study ID:

TOTTG030103

NCT ID:

NCT01516944

Start Date:

February 2012

Completion Date:

December 2018

Related Keywords:

  • Gastric Cancer
  • Tegafur,Gimeracil and Oteracil Potassium Capsules
  • Capecitabine
  • Oxaliplatin
  • perioperative Chemotherapy
  • Gastric Cancer
  • Stomach Neoplasms

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