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

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ClinicalTrials.gov Identifier: NCT02289547
Recruitment Status : Unknown
Verified June 2017 by Byoungyong Shim, The Catholic University of Korea.
Recruitment status was:  Recruiting
First Posted : November 13, 2014
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Byoungyong Shim, The Catholic University of Korea

Brief Summary:
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 .

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Drug: Capecitabine Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 3 Study of Xelox(Capecitabine Plus Oxaliplatin) Followed by Maintenance Capecitabine or Observation in Patients With Advanced Gastric Adenocarcinoma
Study Start Date : May 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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 Name: Xeloda




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289547


Contacts
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Contact: Byoungyong Shim, M.D., Ph.D 82312497126 shimby@catholic.ac.kr
Contact: Ho Jung An, M.D. 82312497135 meicy@catholic.ac.kr

Locations
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Korea, Republic of
St. Vincent's Hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 442-723
Contact: Byoungyong Shim, Ph.D., M.D    82-31-249-8457      
Principal Investigator: Byoungyong Shim, M.D., Ph.D         
Buchon St. Mary's Hospital Recruiting
Buchon, Korea, Republic of
Contact: Cuk Jin Lee         
Daejeon St. Mary's Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Ji Chan Park         
Incheon St. Mary's Hospital Recruiting
Incheon, Korea, Republic of
Contact: Jeo Ho Byen         
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Young Seon Hong         
St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: In Sook Woo         
Bundang Seoul National hospital Recruiting
Sungnam, Korea, Republic of
Contact: Keun Wook Lee         
Ujeongbu St. Mary's Hospital Recruiting
Ujeongbu, Korea, Republic of
Contact: Yoon Ho Ko         
Sponsors and Collaborators
The Catholic University of Korea
Investigators
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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:

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Responsible Party: Byoungyong Shim, Associated professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02289547     History of Changes
Other Study ID Numbers: CMCGA1 Trial
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Byoungyong Shim, The Catholic University of Korea:
chemotherapy
stomach neoplasms

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents