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XELOX for 4 Months Versus 6 Months in Gastric Cancer (LOMAC)

Primary Purpose

Gastric Cancer

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Oxaliplatin

Capecitabine

About this trial

This is an interventional prevention trial for Gastric Cancer focused on measuring Gastric cancer,Adjuvant chemtherapy

Eligibility Criteria

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

Inclusion Criteria:

The lower age limit of research subjects 18 years old and upper age limit of 75 years old.
Be proven to be primary adenocarcinoma of gastric cancer and staged II, IIIA or IIIB by pathological evidence
R0 resection and D2 Gastrectomy
Without any other malignancies
PS (ECOG) of 0 or 1 and expected to survive more than 6 months
No contraindications to chemotherapy, including normal peripheral blood routine, liver, and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L).

Exclusion Criteria:

Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy.
Patients with stage I, IIIC and IV.
Unavailable for R0 resection and D2 Gastrectomy.
Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic infection.
With severe heart disease, including congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease, and resistant hypertension.
Any Known or suspected history of drug allergy test.
The researchers believe the patient is not able to complete the entire course of the experiment.
Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy.
Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases.

Sites / Locations

Anqing Municipal HospitalRecruiting
Anhui Provincial HospitalRecruiting
First Affiliated Hospital of Wannan Medical CollegeRecruiting
Yuebei People's HospitalRecruiting
Shenzhen People's HospitalRecruiting
Jiangxi Provincial Cancer HospitalRecruiting
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
Lishui Hospital of Zhejiang UniversityRecruiting
Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

XELOX for 4 months

XELOX for 6 months

Arm Description

Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery (five 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 4 months or progress of disease

Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery(eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease

Outcomes

Primary Outcome Measures

DFS

Disease-free survival

Secondary Outcome Measures

Adverse Events

Adverse Events of Chemotherapy

Overall survival

Full Information

NCT ID

NCT03399110

First Posted

January 8, 2018

Last Updated

May 29, 2019

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03399110

Brief Title

XELOX for 4 Months Versus 6 Months in Gastric Cancer (LOMAC)

Official Title

XELOX for 4 Months Versus 6 Months as Adjuvant Chemotherapy in Gastric Cancer After D2 Resection (LOMAC)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Our study aims to compare the efficacy and safety of capecitabine and oxaliplatin for 4 months versus 6 months as adjuvant chemotherapy after D2 Gastrectomy in patients with gastric cancer. Hypothesis: For gastric patients after D2 Gastrectomy, capecitabine and oxaliplatin for 4 months show noninferiority to capecitabine and oxaliplatin for 6 months in disease-free survival (DFS) and safety.

Detailed Description

Surgical resection is the cornerstone of treatment for patients with localized gastric cancer. Capecitabine plus oxaliplatin for 6 months after D2 gastrectomy is considered as effective postoperative adjuvant treatment for patients with operable stage II or III gastric cancer in the CLASSIC trail. However, because of adverse events discontinuations in the chemotherapy group occurred in 50 (10%) patients, mainly as a result of nausea, neutropenia, decreased appetite, peripheral neuropathy, diarrhea, and vomiting. At the 2017 ASCO Annual Meeting, Grothey et al reported the result of IDEA trail. For lymph node-positive colon cancer (stage III), some patients may need only half of the long-standing standard course of chemotherapy after surgery. In an analysis of 6 clinical trials with over 12,800 patients, 3 months of chemotherapy was nearly as effective as 6 months in patients with relatively lower recurrence risk and caused fewer side effects, particularly nerve damage. Based on IDEA trail, we postulate that the chemotherapy of capecitabine plus oxaliplatin for 4 months may also benefit patients after D2 gastrectomy and decrease adverse events compared with 6 months.

6. Conditions and Keywords

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

Gastric Cancer

Keywords

Gastric cancer,Adjuvant chemtherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1032 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

XELOX for 4 months

Arm Type

Experimental

Arm Description

Arm Title

XELOX for 6 months

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

Eloxatin

Intervention Description

oxaliplatin 130 mg/m2

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

Capecitabine 1000mg/m2

Primary Outcome Measure Information:

Title

DFS

Description

Disease-free survival

Time Frame

3-year

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Adverse Events of Chemotherapy

Time Frame

1-year

Title

Description

Overall survival

Time Frame

3-year

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: The lower age limit of research subjects 18 years old and upper age limit of 75 years old. Be proven to be primary adenocarcinoma of gastric cancer and staged II, IIIA or IIIB by pathological evidence R0 resection and D2 Gastrectomy Without any other malignancies PS (ECOG) of 0 or 1 and expected to survive more than 6 months No contraindications to chemotherapy, including normal peripheral blood routine, liver, and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L). Exclusion Criteria: Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy. Patients with stage I, IIIC and IV. Unavailable for R0 resection and D2 Gastrectomy. Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic infection. With severe heart disease, including congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease, and resistant hypertension. Any Known or suspected history of drug allergy test. The researchers believe the patient is not able to complete the entire course of the experiment. Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy. Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases.

Central Contact Person:

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

Dazhi Xu, PHD, MD

Phone

(+86) 020-87343737

xudzh@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dazhi Xu, PHD, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anqing Municipal Hospital

City

Anqing

State/Province

Anhui

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yaming Zhang, MD

Facility Name

Anhui Provincial Hospital

City

Hefei

State/Province

Anhui

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xuhui Zhao, MD

First Name & Middle Initial & Last Name & Degree

Facility Name

First Affiliated Hospital of Wannan Medical College

City

Wuhu

State/Province

Anhui

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lianghui Shi, MD

Facility Name

Yuebei People's Hospital

City

Guangzhou

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tao Tao Zhang, MD

Facility Name

Shenzhen People's Hospital

City

Shenzhen

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ligang Xia, MD

Facility Name

Jiangxi Provincial Cancer Hospital

City

Nanchang

State/Province

Jiangxi

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huamin Rao, MD

Facility Name

Second Affiliated Hospital, School of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Chen, MD

Facility Name

Lishui Hospital of Zhejiang University

City

Lishui

State/Province

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hongtao Xu, MD

Facility Name

Tianjin Medical University Cancer Institute and Hospital

City

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rupeng Zhang, MD

12. IPD Sharing Statement

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XELOX for 4 Months Versus 6 Months in Gastric Cancer (LOMAC)

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