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The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer (SIEG)

Primary Purpose

Stage IV Gastric Cancer With Metastasis

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

second line chemoregime for advanced gastric cancer

About this trial

This is an interventional treatment trial for Stage IV Gastric Cancer With Metastasis focused on measuring second line chemoregime, gastric cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Aged between 18 to 70 years
The pathologically confirmed gastric adenocarcinoma and the failure of first-line chemotherapy
Measurable lesions outside the stomach
ECOG(Eastern Cooperative Oncology Group ) score between 0 to 1
Expected survival time of at least 3 months
Subjects receiving treatment for other damage caused has been restored, which it accepted the nitroso or mitomycin interval> 6 weeks, the acceptance of other cytotoxic drugs, radiotherapy or surgery> = 4 weeks, and the wound has completely healed. No bleeding, no nervous system transferred
Blood and organ function was normal

Exclusion criteria:

Comorbid with other malignant tumors
Pregnant and lactating women
with the disease of endangering patient's safety and affecting the completion of the study
Patients suffering from high blood pressure by antihypertensive treatment cannot control (systolic blood pressure> 140mmhg, diastolic blood pressure> 90mmhg,) there is more than Class I and Class I arrhythmia coronary heart disease, with more than Class I heart dysfunction
Major organ failure, such as decompensated heart and lung failure, liver failure, renal failure and patients with intestinal obstruction ipate in other clinical trials of patients in the past four weeks
Participated in clinical trials with other drugs or using other drugs during past 4 weeks
Lesions which can't be measured such as pleural effusion, ascites, peritoneal cancer lesions, diffuse liver and bone metastases violation, brain metastasis

Sites / Locations

Department of Oncology,The First Affiliated Hospital of Anhui Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Irinotecan plus epirubicin

Arm Description

Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment * 6 cycles as the second line chemoregime for advanced gastric cancer

Outcomes

Primary Outcome Measures

PFS and OS

Evaluation progression-free survival (PFS) and overall survival (OS) RECIST(Response Evaluation Criteria In Solid Tumors)1.1: Complete response (CR) Partial response (PR) Stable disease(SD) and progression disease(PD) CR + PR is efficient.

Secondary Outcome Measures

Full Information

NCT ID

NCT01964027

First Posted

January 19, 2012

Last Updated

October 14, 2013

Sponsor

Anhui Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01964027

Brief Title

The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer

Acronym

SIEG

Official Title

The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

July 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Anhui Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime.

Detailed Description

The main purposes: to determine the progression-free survival (PFS) and overall survival (OS) of gastric cancer patients given irinotecan + epirubicin as second-line treatment, who are at Stage IV with disease progressed or recurred after first-line chemotherapy failed, , The Secondary purposes: to determine disease control rate (Disease Control Rate, DCR), the objective response rate (Object Response rate, ORR) and the Quality of life (Quality Of Life, QOL)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage IV Gastric Cancer With Metastasis

Keywords

second line chemoregime, gastric cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Irinotecan plus epirubicin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

second line chemoregime for advanced gastric cancer

Other Intervention Name(s)

irinotecan plus epirubicin

Intervention Description

Primary Outcome Measure Information:

Title

PFS and OS

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Aged between 18 to 70 years The pathologically confirmed gastric adenocarcinoma and the failure of first-line chemotherapy Measurable lesions outside the stomach ECOG(Eastern Cooperative Oncology Group ) score between 0 to 1 Expected survival time of at least 3 months Subjects receiving treatment for other damage caused has been restored, which it accepted the nitroso or mitomycin interval> 6 weeks, the acceptance of other cytotoxic drugs, radiotherapy or surgery> = 4 weeks, and the wound has completely healed. No bleeding, no nervous system transferred Blood and organ function was normal Exclusion criteria: Comorbid with other malignant tumors Pregnant and lactating women with the disease of endangering patient's safety and affecting the completion of the study Patients suffering from high blood pressure by antihypertensive treatment cannot control (systolic blood pressure> 140mmhg, diastolic blood pressure> 90mmhg,) there is more than Class I and Class I arrhythmia coronary heart disease, with more than Class I heart dysfunction Major organ failure, such as decompensated heart and lung failure, liver failure, renal failure and patients with intestinal obstruction ipate in other clinical trials of patients in the past four weeks Participated in clinical trials with other drugs or using other drugs during past 4 weeks Lesions which can't be measured such as pleural effusion, ascites, peritoneal cancer lesions, diffuse liver and bone metastases violation, brain metastasis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yueyin Pan, MD

Phone

865512922987

yueyinpan@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yueyin Pan, MD

Organizational Affiliation

The First Affiliated Hospital of Anhui Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology,The First Affiliated Hospital of Anhui Medical University

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yueyin Pan, MD

Phone

865512922987

yueyinpan@gmail.com

First Name & Middle Initial & Last Name & Degree

Hu Liu, MD

12. IPD Sharing Statement

Learn more about this trial

The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer

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