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

Primary Purpose

Stomach Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Capecitabine
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring chemotherapy, stomach neoplasms

Eligibility Criteria

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

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

Sites / Locations

  • St. Vincent's HospitalRecruiting
  • Buchon St. Mary's HospitalRecruiting
  • Daejeon St. Mary's HospitalRecruiting
  • Incheon St. Mary's HospitalRecruiting
  • Seoul St. Mary's HospitalRecruiting
  • St. Mary's HospitalRecruiting
  • Bundang Seoul National hospitalRecruiting
  • Ujeongbu St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group A

Group B

Arm Description

observational arm

arm of capecitabine maintenance treatment

Outcomes

Primary Outcome Measures

Progression free survival
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression

Secondary Outcome Measures

Overall survival
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until death
quality of life in patients measured by QLQ-c30 and STO-22
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
Toxicity profile of each patients measured by NCI-CTCAE ver 4.0
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression

Full Information

First Posted
October 30, 2014
Last Updated
June 13, 2017
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02289547
Brief Title
Phase 3 Study of Xelox Followed by Maintenance Capecitabine in the Advanced Gastric Cancer
Official Title
Randomized Phase 3 Study of Xelox(Capecitabine Plus Oxaliplatin) Followed by Maintenance Capecitabine or Observation in Patients With Advanced Gastric Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
chemotherapy, stomach neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
No Intervention
Arm Description
observational arm
Arm Title
Group B
Arm Type
Experimental
Arm Description
arm of capecitabine maintenance treatment
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
maintenance capecitabine therapy after six cycles of XELOX
Primary Outcome Measure Information:
Title
Progression free survival
Description
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
Time Frame
From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until death
Time Frame
From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years
Title
quality of life in patients measured by QLQ-c30 and STO-22
Description
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
Time Frame
From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years
Title
Toxicity profile of each patients measured by NCI-CTCAE ver 4.0
Description
every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression
Time Frame
From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Byoungyong Shim, M.D., Ph.D
Phone
82312497126
Email
shimby@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Jung An, M.D.
Phone
82312497135
Email
meicy@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byoungyong Shim, M.D.,Ph.D
Organizational Affiliation
St.Vincent's Hospital of The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young Seon Hong, M.D.,Ph.D
Organizational Affiliation
Seoul St. Mary's Hopital of The Catholic Univerisity of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
In Sook Woo, M.D.,Ph.D
Organizational Affiliation
St. Mary's Hospital of The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Ho Byun, M.D.,Ph.D
Organizational Affiliation
Incheon St. Mary's Hopital of The Catholic Univerisity of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cuk Jin Lee, M.D.,Ph.D
Organizational Affiliation
Bucheon St. Mary's Hopital of The Catholic Univerisity of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ji Chan Park, M.D.,Ph.D
Organizational Affiliation
Daejeon St. Mary's Hopital of The Catholic Univerisity of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoon Ho Ko, M.D.,Ph.D
Organizational Affiliation
Ujeongbu St. Mary's Hopital of The Catholic Univerisity of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keun Wook Lee, M.D.,Ph.D
Organizational Affiliation
Bundang Seoul National Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byoungyong Shim, Ph.D., M.D
Phone
82-31-249-8457
First Name & Middle Initial & Last Name & Degree
Byoungyong Shim, M.D., Ph.D
Facility Name
Buchon St. Mary's Hospital
City
Buchon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuk Jin Lee
Facility Name
Daejeon St. Mary's Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Chan Park
Facility Name
Incheon St. Mary's Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeo Ho Byen
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Seon Hong
Facility Name
St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In Sook Woo
Facility Name
Bundang Seoul National hospital
City
Sungnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keun Wook Lee
Facility Name
Ujeongbu St. Mary's Hospital
City
Ujeongbu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon Ho Ko

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15856038
Citation
De Vita F, Orditura M, Matano E, Bianco R, Carlomagno C, Infusino S, Damiano V, Simeone E, Diadema MR, Lieto E, Castellano P, Pepe S, De Placido S, Galizia G, Di Martino N, Ciardiello F, Catalano G, Bianco AR. A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients. Br J Cancer. 2005 May 9;92(9):1644-9. doi: 10.1038/sj.bjc.6602573.
Results Reference
background
PubMed Identifier
17522863
Citation
Park YH, Lee JL, Ryoo BY, Ryu MH, Yang SH, Kim BS, Shin DB, Chang HM, Kim TW, Yuh YJ, Kang YK. Capecitabine in combination with Oxaliplatin (XELOX) as a first-line therapy for advanced gastric cancer. Cancer Chemother Pharmacol. 2008 Apr;61(4):623-9. doi: 10.1007/s00280-007-0515-7. Epub 2007 May 24.
Results Reference
background
PubMed Identifier
20676676
Citation
Waddell T, Gollins S, Soe W, Valle J, Allen J, Bentley D, Morris J, Lloyd A, Swindell R, Taylor MB, Saunders MP. Phase II study of short-course capecitabine plus oxaliplatin (XELOX) followed by maintenance capecitabine in advanced colorectal cancer: XelQuali study. Cancer Chemother Pharmacol. 2011 May;67(5):1111-7. doi: 10.1007/s00280-010-1322-0. Epub 2010 Jul 30.
Results Reference
background
PubMed Identifier
19153121
Citation
Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009 Apr;20(4):666-73. doi: 10.1093/annonc/mdn717. Epub 2009 Jan 19.
Results Reference
background
PubMed Identifier
18172173
Citation
Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149.
Results Reference
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Phase 3 Study of Xelox Followed by Maintenance Capecitabine in the Advanced Gastric Cancer

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