Oxaliplatin plus S-1 or capecitabine chemotherapy before or after surgery for locally advanced gastric cancer with D2 lymphadenectomy: a phase II-III randomized trial

Phase 2

Completed

• Conditions: ocally advanced gastric cancer; Cancer; Gastric cancer

• Registration Number: ISRCTN12206108
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30510363

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-12-31
• Study Start: 2018-03-07
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1. Aged between 18 and 80 years
2. Pathologically confirmed gastric adenocarcinoma
3. Disease at the clinical stage of resectable advanced gastric cancer (T2-4NanyM0), without peritoneal metastasis as confirmed by laparoscopy and cytological pathology
4. Eastern Cooperative Oncology Group performance status of 0 or 1
5. No previous treatment history
6. Adequate organ function levels (hematological ANC =1.5x10(9)/l, hemoglobin =9 g/dl, platelets = 100x10(9)/l, hepatic albumin =30 g/l, serum bilirubin =1.5x the upper limit of normal [ULN], AST and ALT =2.5×ULN, ALP =2.5×ULN, TBIL =1.5×ULN, renal serum creatinine <1.5xULN)
7. Adequate lung and heart function, without ECG-confirmed ischemic change or ventricular arrhythmias

Exclusion Criteria

1. Serious comorbidities
2. Distant metastasis
3. Acute inflammation
4. Systematic steroid therapy
5. Pregnant or breast-feeding women or women considering pregnancy
6. Nervous system disorder or psychiatric disease
7. Medical history of allergy or hypersensitivity to any drugs
8. Patient refusal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (time interval from the time of randomization to the date of all-cause death or last follow-up). Follow-up was conducted by phone call every 6 months after completion or termination of treatment.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints included treatment completion rate, surgical complications, chemotherapy adverse events and pathological complete response rate. Treatment completion rate was recorded when the treatment was completed or stopped. Surgical complications were measured during and after surgery. Complete response rate was reported by pathologists after the surgery. Pathological stage was evaluated according to the 7th edition of the American Joint Committee on Cancer TNM Staging Classification for Carcinoma of the Stomach. The clinical response was evaluated by the Response Evaluation Criteria for Solid Tumors (RECIST) in computed tomography and by the downstaging assessed by endoscopic ultrasound using Choi criteria by the end of the second cycle of neoadjuvant chemotherapy (NACT). Pathology response to NACT was evaluated according to the 3rd English edition of the Japanese Classification of Gastric Cancer.