Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

NCT ID: NCT01516944

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 749 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

postoperative chemotherapy,SOX

Group Type: ACTIVE_COMPARATOR

Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin

Intervention Type: DRUG

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

Perioperative chemotherapy,SOX

Group Type: EXPERIMENTAL

Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin

Intervention Type: DRUG

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

Perioperative chemotherapy,XELOX

Group Type: EXPERIMENTAL

Oxaliplatin; Capecitabine

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

S-1; Oxaliplatin; S-1; Oxaliplatin; Oxaliplatin; Capecitabine

Eligibility 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 T3/4NxM0
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qun Zhao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qun Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University

Locations

Department of General Surgery

Shijiazhuang, Hebei, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37501640 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32583567 (View on PubMed)

Other Identifiers

TOTTG030103

Identifier Type: -

Identifier Source: org_study_id