Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Hebei Medical University
Sponsor:
Information provided by (Responsible Party):
Qun Zhao, Hebei Medical University
ClinicalTrials.gov Identifier:
NCT01516944
First received: January 10, 2012
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

Stage I:Neoadjuvant therapy

  • Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin

Stage II: Perioperative therapy

  • Perioperative Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to adjuvant Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin
  • A regimen of Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic gastric cancer. The investigators assessed whether the addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced gastric cancer.

Condition Intervention Phase
Gastric Cancer
Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules;Oxaliplatin
Drug: Oxaliplatin; Capecitabine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Hebei Medical University:

Primary Outcome Measures:
  • Disease-free survival(DFS) [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Disease control rate (DCR) [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
    To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria

  • Down staging rate [ Time Frame: Within 3 weeks after surgery ] [ Designated as safety issue: No ]
    After the pathological examination of resected specimen

  • Overall survival (OS) [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Side effects during observation ] [ Designated as safety issue: Yes ]
    Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit.

  • R0-resection rate [ Time Frame: Within 3 weeks after surgery ] [ Designated as safety issue: No ]
    After the pathological examination of resected specimen


Estimated Enrollment: 729
Study Start Date: February 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: postoperative chemotherapy,SOX Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules;Oxaliplatin
Tegafur,Gimeracil and Oteracil Potassium Capsules 80 mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation
Other Names:
  • S-1
  • Oxaliplatin
Experimental: Perioperative chemotherapy,SOX Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules;Oxaliplatin
Tegafur,Gimeracil and Oteracil Potassium Capsules 80mg/㎡ ,D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycles preoperation, Tegafur,Gimeracil and Oteracil Potassium Capsules ,80 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for six cycles postoperation
Other Names:
  • S-1
  • Oxaliplatin
Experimental: Perioperative chemotherapy,XELOX Drug: Oxaliplatin; Capecitabine
Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycle pre-operation, Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/m2 D1 q3wk for six cycles postoperation
Other Names:
  • Oxaliplatin
  • Capecitabine

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516944

Locations
China, Hebei
Department of General Surgery Recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Qun Zhao, doctor    +8613930162111    zhaoqun516@yahoo.com.cn   
Principal Investigator: Qun Zhao, Doctor         
Sponsors and Collaborators
Hebei Medical University
Investigators
Principal Investigator: Qun Zhao, Doctor Hebei Medical University
  More Information

No publications provided

Responsible Party: Qun Zhao, Principal Investigator, Hebei Medical University
ClinicalTrials.gov Identifier: NCT01516944     History of Changes
Other Study ID Numbers: TOTTG030103
Study First Received: January 10, 2012
Last Updated: October 10, 2013
Health Authority: China: Ethics Committee

Keywords provided by Hebei Medical University:
Tegafur,Gimeracil and Oteracil Potassium Capsules
Capecitabine
Oxaliplatin
perioperative Chemotherapy
Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Tegafur
Capecitabine
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014