SVOSA: Comparison of SEEOX and SOX Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients

Sponsor

Jinling Hospital, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT02338518

Collaborator

(none)

320

Enrollment

Location

Arms

Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chemotherapy is an important therapeutic method for unresectable gastric cancer patients. However, there is currently no established standard chemotherapeutic regimen for gastric cancer. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX regimens. The investigators estimate that combined intravenous and intra-arterial intensified SEEOX neoadjuvant chemotherapy may be a safe and promising regimen in unresectable gastric cancer patients.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms Gastric Cancer	Drug: oxaliplatin Drug: etoposide Drug: pharmorubicin Drug: S-1	Phase 3

Detailed Description

Gastric cancer patients who will receive neoadjuvant chemotherapy would be included in this study. They would receive combined intravenous and intra-arterial intensified SEEOX neoadjuvant chemotherapy or SOX regimen at random. The efficacy and toxicity of these two regimens would be compared.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of SEEOX and SOX Chemotherapeutic Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SEEOX group A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, oxaliplatin 100 mg/m2, etoposide 80 mg/m2, and pharmorubicin 30 mg/m2 were administered from the celiac artery on day 1. 80 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle.	Drug: oxaliplatin oxaliplatin 100 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group and SOX group. Intravenous oxaliplatin 130 mg/m2 was administered on day 1 of every cycle in SOX group. Drug: etoposide etoposide 80 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group. Drug: pharmorubicin pharmorubicin 30 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group. Drug: S-1 80 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks in both SEEOX and SOX groups.
Active Comparator: SOX group A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, patients received intravenous oxaliplatin 130 mg/m2 on day 1, and 80 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle.	Drug: oxaliplatin oxaliplatin 100 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group and SOX group. Intravenous oxaliplatin 130 mg/m2 was administered on day 1 of every cycle in SOX group. Drug: S-1 80 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks in both SEEOX and SOX groups.

Arm

Intervention/Treatment

Experimental: SEEOX group

A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, oxaliplatin 100 mg/m2, etoposide 80 mg/m2, and pharmorubicin 30 mg/m2 were administered from the celiac artery on day 1. 80 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle.

Drug: oxaliplatin

oxaliplatin 100 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group and SOX group. Intravenous oxaliplatin 130 mg/m2 was administered on day 1 of every cycle in SOX group.

Drug: etoposide

etoposide 80 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.

Drug: pharmorubicin

pharmorubicin 30 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.

Drug: S-1

80 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks in both SEEOX and SOX groups.

Active Comparator: SOX group

A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, patients received intravenous oxaliplatin 130 mg/m2 on day 1, and 80 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle.

Drug: oxaliplatin

Drug: S-1

80 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks in both SEEOX and SOX groups.

Outcome Measures

Primary Outcome Measures

2 year overall survival [up to 5 years]

Secondary Outcome Measures

R0 resection rate [up to 3 years]

Other Outcome Measures

Response Evaluation Criteria in Solid Tumors (RECIST) [up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Eastern Cooperative Oncology Group(ECOG) score 0-2
Ambulatory males or females, aged 30-70 years.
Unresectable gastric cancer (Tumors with bulky nodal metastases surrounding the celiac artery and its branches or invasion of adjacent structures such as pancreas, omentum, esophagus, and aorta were considered unresectable)
Life expectancy more than 3 months
Give written informed consent, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Normal hepatic, renal, and bone marrow function (GPT<2 fold of upper limit value; white blood cell count>4000/dl, Tbil<1.5mg/dl, Cr<1.5 fold of upper limit value)

Exclusion Criteria:

Patients can not bear surgical procedure.
Pregnant or lactating women.
Previous cytotoxic chemotherapy, radiotherapy or immunotherapy.
History of another malignancy within the last five years.
History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
Organ allografts requiring immunosuppressive therapy.
Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
Moderate or severe renal impairment: serum creatinine > 1.5 x upper limit of normal (ULN).
Hypersensitivity to any drug of the study regimen.
With abdominal cavity implantation metastasis or distant metastasis.
Unwilling or unable to comply with the protocol for the duration of the study.