Perioperative Chemotherapy for Potentially Resectable Gastric Cancer
This study is currently recruiting participants.
Verified July 2012 by Hebei Medical University
Sponsor:
Hebei Medical University
Information provided by (Responsible Party):
Qun Zhao, Hebei Medical University
ClinicalTrials.gov Identifier:
NCT01516944
First received: January 10, 2012
Last updated: July 8, 2012
Last verified: July 2012
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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:
|
| 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:
|
| 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:
|
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
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: | July 8, 2012 |
| 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 June 17, 2013