Clinical trial NCT01542294: SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer
Official title: Phase I/II Study of Oral S-1 Plus f Oxaliplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer
S-1
oxaliplatin
adjuvant chemotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2012-03-02
Enrollment: 71
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.

Detailed description: This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.

Eligibility criteria: Inclusion Criteria:

* 20-70 years
* Histologically proven adenocarcinoma of the stomach
* Curative D2 lymphadenectomy resection for gastric cancer, who can start chemotherapy be within 6 weeks after surgery
* Stage II, III (AJCC 7th edition)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* No prior chemotherapy or radiotherapy
* Adequate bone marrow, renal, and liver function

Exclusion Criteria:

* Any evidence of metastatic disease (including presence of tumor cells in the ascites).
* Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
* Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
* Pregnant or lactating women.
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
* Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
* Organ allografts requiring immunosuppressive therapy.
* Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
* Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency. Hypersensitivity to platinum compounds or any of the components of the study medications.
* Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before enter the trial.

Primary outcomes:
measure: chemotherapy complete rate
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 years
measure: recurrence-free survival(RFS)
timeFrame: 3 years
measure: overall survival(OS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Medical Oncology,Cancer hospital and Institute,CAMS
Study officials:
affiliation: Department of Medical Oncology,Cancer Hospital and Institute,CAMS
name: Lin Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang G, Zhao J, Song Y, Zhang W, Sun Y, Zhou A, Huang J, Du F, Yang L. Phase II study of adjuvant chemotherapy with S1 plus oxaliplatin for Chinese patients with gastric cancer. BMC Cancer. 2018 May 9;18(1):547. doi: 10.1186/s12885-018-4480-9.