Back to resultsChemotherapy Options for the First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Capecitabine/cisplatin
S-1/cisplatin
Capecitabine/oxaliplatin
5-fluorouracil/oxaliplatin
Capecitabine
S-1
5-fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, elderly, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- .Metastatic or recurrent, histologically confirmed adenocarcinoma of stomach - Previously untreated patients, including patients with previous adjuvant chemotherapy completed more than 6 months
- 70 yrs or older
- Eastern Cooperative Oncology Group 0-2
- Measurable or evaluable disease
Adequate major organ functions
- Hb ≥ 9.0 g/dL
- White blood cell count ≥ 3000/μL
- Absolute Neutrophil Count (ANC) ≥ 1500/μL [*ANC = neutrophil segs ＋ neutrophil bands]
- Platelet ≥ 100 × 103/ μL
- Total bilirubin ≤ 1.5 ×UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3.0x UNL(in case of liver metastasis, AST/ALT ≤ 5.0 x UNL)
- Serum creatinine ≤ 1.5 × UNL (in case of serum creatinine > 1.5 mg/dL , Ccr should be >= 50 mL/min, Ccr is calculated by Cockcroft-Gault or 24hr urine collection)
- Life expectancy > 3month
- Written informed consent
Exclusion Criteria:
- Metastatic or recurrent stomach cancer other than adenocarcinoma
- HER-2 positive
- Clinically significant, uncontrolled gastric outlet obstruction, bleeding, or perforation
- Radiation therapy within the previous 2wks
- Major surgery or trauma within the previous 4wks
- Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
- Uncontrolled brain metastasis
- Presence of other serious disease (cardiovascular, hepatic, infection etc.)
- Patients who participated in other clinical trials within the previous 30days
- Men of childbearing potential not willing to use effective means of contraception
Sites / Locations
- Hallym University Sacred Heart Hospital
- Inje University Haeundae Paik Hospital
- Chungbuk National University Hospital
- Kyungpook National University Medical Center
- Yeongnam University Medical Center
- National Cancer Center
- Gachon University Gil Medical Center
- Inje University Pusan Paik Hospital
- Seoul National University Bundang Hospital
- Asan Medical Center
- SMG-SNU Boramae Medical Center
- Inje University Sanggye Paik Hospital
- Kangbuk Samsung Hospital
- The Catholic University of Korea Uijeongbu St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Platinum/fluoropyrimidine combination chemotherapy
Fluoropyrimidine monochemotherapy
Arm Description
Outcomes
Primary Outcome Measures
comparison of overall survival
Secondary Outcome Measures
comparison of progression-free survival
comparison of response rate
comparison of adverse events
comparison of quality of life
Full Information
NCT ID
NCT02114359
First Posted
April 9, 2014
Last Updated
October 22, 2020
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea, Korean Cancer Study Group
1. Study Identification
Unique Protocol Identification Number
NCT02114359
Brief Title
Chemotherapy Options for the First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer
Official Title
Comparison of Efficacy and Tolerance Between Combination Therapy and Monotherapy as a First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer; Multicenter Randomized Phase 3 Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea, Korean Cancer Study Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators compare the overall survival between combination chemotherapy and monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. The investigators also compare the progression free survival, response rate, safety, and, quality of life between two groups, and evaluate that the comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance of treatment, survival of the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, elderly, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platinum/fluoropyrimidine combination chemotherapy
Arm Type
Experimental
Arm Title
Fluoropyrimidine monochemotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Capecitabine/cisplatin
Intervention Description
Capecitabine/cisplatin (XP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv over 15min D1, capecitabine 1000mg/m2 (80% dose of 1250mg/m2) po bid D1-14, q 3wks
Intervention Type
Drug
Intervention Name(s)
S-1/cisplatin
Intervention Description
S-1/cisplatin (SP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv ov 15min D1, S-1 30mg/m2 (80% dose of 40mg/m2) po bid D1-14, q3wks
Intervention Type
Drug
Intervention Name(s)
Capecitabine/oxaliplatin
Intervention Description
Capecitabine+oxaliplatin (XELOX): oxaliplatin 100mg/m2 (80% dose of 130mg/m2)iv ov 120min D1, capecitabine 800mg/m2 (80% dose of 1000mg/m2) po bid D1-14, q3wks
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil/oxaliplatin
Intervention Description
5-fluorouracil/oxaliplatin (FOLFOX): oxaliplatin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, leucovorin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, 5-fluorouracil 1900mg/m2 (80% dose of 2400mg/m2) iv ov 46h D1, q 2wks
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 1000mg/m2 po bid)
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 30mg/m2 po bid)
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Description
5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks
Primary Outcome Measure Information:
Title
comparison of overall survival
Time Frame
upto 3years
Secondary Outcome Measure Information:
Title
comparison of progression-free survival
Time Frame
upto 2years
Title
comparison of response rate
Time Frame
upto 2years
Title
comparison of adverse events
Time Frame
upto 2yrs
Title
comparison of quality of life
Time Frame
upto 2years
Other Pre-specified Outcome Measures:
Title
comprehensive geriatric assessment
Description
The investigators are going to evaluate that comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance to treatment, survival of patients.
Comprehensive geriatric assessment will not necessarily be tested in all subjects, but instead, screening tool (KG-7 (Korean screening tool for the elderly)) will be tested in all subjects.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
.Metastatic or recurrent, histologically confirmed adenocarcinoma of stomach - Previously untreated patients, including patients with previous adjuvant chemotherapy completed more than 6 months
70 yrs or older
Eastern Cooperative Oncology Group 0-2
Measurable or evaluable disease
Adequate major organ functions
Hb ≥ 9.0 g/dL
White blood cell count ≥ 3000/μL
Absolute Neutrophil Count (ANC) ≥ 1500/μL [*ANC = neutrophil segs ＋ neutrophil bands]
Platelet ≥ 100 × 103/ μL
Total bilirubin ≤ 1.5 ×UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3.0x UNL(in case of liver metastasis, AST/ALT ≤ 5.0 x UNL)
Serum creatinine ≤ 1.5 × UNL (in case of serum creatinine > 1.5 mg/dL , Ccr should be >= 50 mL/min, Ccr is calculated by Cockcroft-Gault or 24hr urine collection)
Life expectancy > 3month
Written informed consent
Exclusion Criteria:
Metastatic or recurrent stomach cancer other than adenocarcinoma
HER-2 positive
Clinically significant, uncontrolled gastric outlet obstruction, bleeding, or perforation
Radiation therapy within the previous 2wks
Major surgery or trauma within the previous 4wks
Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
Uncontrolled brain metastasis
Presence of other serious disease (cardiovascular, hepatic, infection etc.)
Patients who participated in other clinical trials within the previous 30days
Men of childbearing potential not willing to use effective means of contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IN SIL CHOI, M.D., Ph.D.
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
ZIP/Postal Code
431-796
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongju
ZIP/Postal Code
361-711
Country
Korea, Republic of
Facility Name
Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
702-210
Country
Korea, Republic of
Facility Name
Yeongnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
400-713
Country
Korea, Republic of
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Uijeongbu St. Mary's Hospital
City
Uijeongbu
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
8508349
Citation
Kim NK, Park YS, Heo DS, Suh C, Kim SY, Park KC, Kang YK, Shin DB, Kim HT, Kim HJ, et al. A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer. 1993 Jun 15;71(12):3813-8. doi: 10.1002/1097-0142(19930615)71:123.0.co;2-5.
Results Reference
background
PubMed Identifier
12506170
Citation
Ohtsu A, Shimada Y, Shirao K, Boku N, Hyodo I, Saito H, Yamamichi N, Miyata Y, Ikeda N, Yamamoto S, Fukuda H, Yoshida S; Japan Clinical Oncology Group Study (JCOG9205). Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205). J Clin Oncol. 2003 Jan 1;21(1):54-9. doi: 10.1200/JCO.2003.04.130.
Results Reference
background
PubMed Identifier
10894863
Citation
Vanhoefer U, Rougier P, Wilke H, Ducreux MP, Lacave AJ, Van Cutsem E, Planker M, Santos JG, Piedbois P, Paillot B, Bodenstein H, Schmoll HJ, Bleiberg H, Nordlinger B, Couvreur ML, Baron B, Wils JA. Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: A trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. J Clin Oncol. 2000 Jul;18(14):2648-57. doi: 10.1200/JCO.2000.18.14.2648.
Results Reference
background
PubMed Identifier
1801881
Citation
Lacave AJ, Baron FJ, Anton LM, Estrada E, De Sande LM, Palacio I, Esteban E, Gracia JM, Buesa JM, Fernandez OA, et al. Combination chemotherapy with cisplatin and 5-fluorouracil 5-day infusion in the therapy of advanced gastric cancer: a phase II trial. Ann Oncol. 1991 Nov-Dec;2(10):751-4. doi: 10.1093/oxfordjournals.annonc.a057858.
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
18282805
Citation
Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. doi: 10.1016/S1470-2045(08)70035-4. Epub 2008 Feb 20.
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
background
PubMed Identifier
18665164
Citation
Lee JL, Kang YK, Kang HJ, Lee KH, Zang DY, Ryoo BY, Kim JG, Park SR, Kang WK, Shin DB, Ryu MH, Chang HM, Kim TW, Baek JH, Min YJ. A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer. Br J Cancer. 2008 Aug 19;99(4):584-90. doi: 10.1038/sj.bjc.6604536. Epub 2008 Jul 29.
Results Reference
background
PubMed Identifier
10765119
Citation
Koizumi W, Kurihara M, Nakano S, Hasegawa K. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. For the S-1 Cooperative Gastric Cancer Study Group. Oncology. 2000 Apr;58(3):191-7. doi: 10.1159/000012099.
Results Reference
background
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Chemotherapy Options for the First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer
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