Phase 3 Study of Xelox Followed by Maintenance Capecitabine in the Advanced Gastric Cancer

June 13, 2017 updated by: Byoungyong Shim, The Catholic University of Korea

Randomized Phase 3 Study of Xelox(Capecitabine Plus Oxaliplatin) Followed by Maintenance Capecitabine or Observation in Patients With Advanced Gastric Adenocarcinoma

XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. We study that randomized Phase III study of Xelox (Capecitabine plus Oxaliplatin) followed by maintenance Capecitabine or Observation in the gastric cancer patients of stable disease after 6 cycle 1st line of XELOX chemotherapy .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study rationale : Park et al. observed the oxaliplatin as part of XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. The response with XELOX regimen generally occurs earlier. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. This regimen was studied in colon and breast cancer.

- Objective: Primary: To evaluate progression free survival Secondary: To evaluated overall survival, response rate, toxicity profile of chemotherapy, quality of life

  • Design :Multicenter randomized controlled phase III open label trial Study subjects will be randomized to two groups in a ratio of 1:1 Subjects More than stable disease after 6 cycle 1st line of XELOX chemotherapy (OR non-complete response/non-progressive disease in cases of non-measurable disease before XELOX chemotherapy),
  • Treatment Groups Group A : Capecitabine: Capecitabine 1000mg/m2 bid D1-14, q 3 week Group B : Observation
  • Evaluation of response and toxicity A response will be evaluated radiologically every two cycles thereafter, or when progression is suspicious by RECIST criteria version 1.1.

A progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause.

An overall survival is defined as the time from the 1stdate of chemotherapy to the date of death.

Safety will be evaluated every treatment by NCI-CTCAE version 4.0.

Study Type

Interventional

Enrollment (Anticipated)

184

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Buchon, Korea, Republic of
        • Recruiting
        • Buchon St. Mary's Hospital
        • Contact:
          • Cuk Jin Lee
      • Daejeon, Korea, Republic of
        • Recruiting
        • Daejeon St. Mary's hospital
        • Contact:
          • Ji Chan Park
      • Incheon, Korea, Republic of
        • Recruiting
        • Incheon St. Mary's Hospital
        • Contact:
          • Jeo Ho Byen
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul St. Mary's Hospital
        • Contact:
          • Young Seon Hong
      • Seoul, Korea, Republic of
        • Recruiting
        • St. Mary's Hospital
        • Contact:
          • In Sook Woo
      • Sungnam, Korea, Republic of
        • Recruiting
        • Bundang Seoul National hospital
        • Contact:
          • Keun Wook Lee
      • Ujeongbu, Korea, Republic of
        • Recruiting
        • Ujeongbu St. Mary's Hospital
        • Contact:
          • Yoon Ho Ko
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 442-723
        • Recruiting
        • St. Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven gastric cancer
  • Minimum age of 18 years
  • Stage IV (regardless of the presence or absence of measurable disease by RECIST criteria) or recurrent after curative surgery
  • Negative expression (0, 1) of Her2 Immuno-histochemistry or negative amplification of FISH in Her2 Immuno-histochemistry 2+
  • More than stable disease after 6 cycle 1st line of XELOX chemotherapy (OR non-Complete response/non-Progressive disease in cases of non-measurable disease before XELOX chemotherapy)
  • Eastern Cooperative Oncology Group Performance status 0-2
  • Adequate bone marrow function: Absolute neutrophil count ≥ 1,500/ul, Hemoglobin ≥ 8 g/dL, platelet ≥ 100,000/μl
  • Adequate renal function: Serum creatinine ≤ 1.5 x ULN (upper normal limit) or creatinine clearance ≥ 60 ml/min
  • Adequate hepatic function: serum bilirubin ≤ 2.5 x UNL, AST and ALT ≤ 2.5 x UNL (≤ 5 x ULN in the presence of liver metastasis)
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

  • Patients who were exposed previously to any chemotherapy except XELOX for advanced disease
  • Patients who received R0 or R1 resection for metastatic or recurrent gastric cancer and without evaluable/measurable disease
  • Disease relapsed during or within 4 months after adjuvant therapy
  • Patients who had central nervous system and meningeal metastases
  • Patients with significant neurologic or psychiatric disorders
  • Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
  • Any previous or concurrent malignancy except for adequately treated non-melanoma skin cancer, in situ cancer of uterine cervix, non-muscle invasive bladder cancer or malignancy without evidence of recurrence within 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group A
observational arm
Experimental: Group B
arm of capecitabine maintenance treatment
Drug: Capecitabine
maintenance capecitabine therapy after six cycles of XELOX
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until death
From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
quality of life in patients measured by QLQ-c30 and STO-22
Time Frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
Toxicity profile of each patients measured by NCI-CTCAE ver 4.0
Time Frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Byoungyong Shim, M.D.,Ph.D, St.Vincent's Hospital of The Catholic University of Korea
  • Principal Investigator: Young Seon Hong, M.D.,Ph.D, Seoul St. Mary's Hopital of The Catholic Univerisity of Korea
  • Principal Investigator: In Sook Woo, M.D.,Ph.D, St. Mary's Hospital of The Catholic University of Korea
  • Principal Investigator: Jae Ho Byun, M.D.,Ph.D, Incheon St. Mary's Hopital of The Catholic Univerisity of Korea
  • Principal Investigator: Cuk Jin Lee, M.D.,Ph.D, Bucheon St. Mary's Hopital of The Catholic Univerisity of Korea
  • Principal Investigator: Ji Chan Park, M.D.,Ph.D, Daejeon St. Mary's Hopital of The Catholic Univerisity of Korea
  • Principal Investigator: Yoon Ho Ko, M.D.,Ph.D, Ujeongbu St. Mary's Hopital of The Catholic Univerisity of Korea
  • Principal Investigator: Keun Wook Lee, M.D.,Ph.D, Bundang Seoul National hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 13, 2014

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMCGA1 Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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