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

NCT02338518 | Unknown Phase 3

• 2 other identifiers: 2014062108Z28
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy is an important therapeutic method for patients with advanced gastric cancer. However, there is currently no established standard chemotherapeutic regimen in the preoperative or neoadjuvant treatment setting. 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 preoperative chemotherapy may be a safe and promising regimen for locally advanced or initially unresectable gastric cancer patients.

Conditions

Stomach Neoplasms; Gastric Cancer

Keywords

gastric cancer; neoadjuvant chemotherapy; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• 3 year progression free survival

  time period calculated from randomization to the first disease progression, recurrence or death from any cause

  up to 7 years

Secondary Outcomes (4)

• Objective response rate

  up to 4 years

• R0 resection rate

  up to 4 years

• 3 year overall survival

  up to 7 years

• Adverse events of preoperative chemotherapy

  up to 4 years

Other Outcomes (1)

• Sensitivity analysis of primary outcome adjusted for stratification factors

  up to 7 years

Study Arms (2)

SEEOX group

EXPERIMENTAL

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. 80～120 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: etoposide; Drug: pharmorubicin; Drug: S-1

SOX group

ACTIVE COMPARATOR

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\~120 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

Interventions

oxaliplatin DRUG

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.

SEEOX group; SOX group

etoposide DRUG

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

SEEOX group

pharmorubicin DRUG

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

Also known as: epirubicin

SEEOX group

S-1 DRUG

80\~120 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.

SEEOX group; SOX group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Etoposide; Epirubicin; S 1 (combination)

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides

Study Officials

• Guoli Li, M.D.

  Jinlin Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: January 14, 2015
• Study Start: January 4, 2015
• Primary Completion: May 21, 2019
• Study Completion: October 1, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

CN (1)