Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

NCT01516944 | Completed Phase 2

• 1 other identifier: TOTTG030103
• Study Type: interventional
• Target: 749
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

Tegafur，Gimeracil and Oteracil Potassium Capsules; Capecitabine; Oxaliplatin; perioperative Chemotherapy; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival(DFS)

  3 year

Secondary Outcomes (6)

• Objective response rate (ORR)

  At the end of the study

• Disease control rate (DCR)

  At the end of the study

• Down staging rate

  Within 3 weeks after surgery

• Overall survival (OS)

  5 year

• Adverse events

  Side effects during observation

Study Arms (3)

postoperative chemotherapy,SOX

ACTIVE COMPARATOR

Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin

Perioperative chemotherapy,SOX

EXPERIMENTAL

Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin

Perioperative chemotherapy,XELOX

EXPERIMENTAL

Drug: Oxaliplatin; Capecitabine

Interventions

Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin DRUG

Tegafur，Gimeracil and Oteracil Potassium Capsules 80 mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation

Also known as: S-1, Oxaliplatin

postoperative chemotherapy,SOX

Oxaliplatin; Capecitabine DRUG

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

Also known as: Oxaliplatin, Capecitabine

Perioperative chemotherapy,XELOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 -75
• Histologically or cytologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction)
• ECOG performance status ≦2
• Tumor stage T3/4NxM0
• No distant metastasis (M0)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

Department of General Surgery

Shijiazhuang, Hebei, 050011, China

Location

Related Publications (2)

• Ding P, Wu J, Wu H, Sun C, Meng M, Lowe S, Tian Y, Guo H, Meng L, Zhao Q. Comment on 'Hand grip strength-based cachexia index as a predictor of cancer cachexia and prognosis in patients with cancer' by Xie et al. J Cachexia Sarcopenia Muscle. 2023 Oct;14(5):2449-2451. doi: 10.1002/jcsm.13298. Epub 2023 Jul 28. No abstract available.

  PMID: 37501640 DERIVED

• Zhao Q, Lian C, Huo Z, Li M, Liu Y, Fan L, Tan B, Zhao X, Zhang Z, Wang D, Liu Y, Guo H, Yang P, Tian Y, Li Y. The efficacy and safety of neoadjuvant chemotherapy on patients with advanced gastric cancer: A multicenter randomized clinical trial. Cancer Med. 2020 Aug;9(16):5731-5745. doi: 10.1002/cam4.3224. Epub 2020 Jun 24.

  PMID: 32583567 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Tegafur; gimeracil; S 1 (combination); Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Qun Zhao, Doctor

  Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 25, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

CN (1)