To compare disease free survival of patient with gastric cancer between 2 treatment regimens.

To compare disease free survival between conventional method and chemotherapy before surgery in patient with gastric cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138901111155N7

Enrollment

Registered

2010-09-10

Start date

2010-07-06

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer. Malignant neoplasm of stomach, Stomach, unspecified Stomach

Interventions

Intervention 1: In neo-adjuvant group (Cases)

patients receive chemotherapy (Cisplatin 20mg/m2 and 5FU 325mg/m2) and simultaneous abdomen and stomach Cobalt radiotherapy before radical surgery of the stomach. Finally, they receive ECX regimen

Xeloda (Capecitabin 625 mg) twice a day and Epirubicin 50 mg/m2 for 2 weeks. Intervention 2: In adjuvant group (Controls)

patients undergo radical surgery then receive chemotherapy (Leukotrien 30mg/m2 for 4 days and 5FU 325mg/m2) and abdomen and stomach Cobalt radiotherapy in the first and last weeks, and after that rece

Xeloda (Capecitabin 625 mg) twice a day and Epirubicin 50 mg/m2 for 2 weeks.

Treatment - Drugs

In adjuvant group (Controls)

In neo-adjuvant group (Cases)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Primary gastric cancer in non cardiac area, No distant metastasis, Age less than 70 years old, Normal CBC (Hb>10, Plt>100/000, WBC>4000, PMN>1500), normal liver and kidney function, Satisfaction of patients to do this treatment, Conformance of surgeon for operation, No excessive changes in patients' weight, Carnofski criteria>70 Exclusion criteria: History of other cancers (instead of non melanocytic cancer of skin, History of major medical diseases (Intensive heart and/or lung disease)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Response to neoadjuvant therapy. Timepoint: After surgery; every month until 3 months, every 3 months until 6 months and every 6 months until 36 months. Method of measurement: pathological report.;Disease free time. Timepoint: Every month until 3 months, every 3 months until 6 month, every 6 month until the end of follow up. Method of measurement: In years, pathologic results during the follow-ups.	—

Measure

Time frame

Response to neoadjuvant therapy. Timepoint: After surgery; every month until 3 months, every 3 months until 6 months and every 6 months until 36 months. Method of measurement: pathological report.;Disease free time. Timepoint: Every month until 3 months, every 3 months until 6 month, every 6 month until the end of follow up. Method of measurement: In years, pathologic results during the follow-ups.

—

Secondary

Measure	Time frame
Side effects of the treetment. Timepoint: Every month until 3 months, every 3 months until 6 months, every 6 months until the end of follow up. Method of measurement: Interview and physical exam.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarahnaz Joukar

Gastrointestinal and Liver Diseases Research Center

F_Jokar@gums.ac.ir www.gldrc.org00981315535116-00989113811118

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026