ClinicalTrials.gov
ClinicalTrials.gov Menu

Chemotherapy Options for the First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02114359
Recruitment Status : Recruiting
First Posted : April 15, 2014
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
Ministry of Health & Welfare, Korea
Korean Cancer Study Group
Information provided by (Responsible Party):
In Sil Choi, SMG-SNU Boramae Medical Center

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Capecitabine/cisplatin Drug: S-1/cisplatin Drug: Capecitabine/oxaliplatin Drug: 5-fluorouracil/oxaliplatin Drug: Capecitabine Drug: S-1 Drug: 5-fluorouracil Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Platinum/fluoropyrimidine combination chemotherapy Drug: Capecitabine/cisplatin
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

Drug: S-1/cisplatin
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

Drug: Capecitabine/oxaliplatin
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

Drug: 5-fluorouracil/oxaliplatin
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

Active Comparator: Fluoropyrimidine monochemotherapy Drug: Capecitabine
Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 1000mg/m2 po bid)

Drug: S-1
S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 30mg/m2 po bid)

Drug: 5-fluorouracil
5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks




Primary Outcome Measures :
  1. comparison of overall survival [ Time Frame: upto 3years ]

Secondary Outcome Measures :
  1. comparison of progression-free survival [ Time Frame: upto 2years ]
  2. comparison of response rate [ Time Frame: upto 2years ]
  3. comparison of adverse events [ Time Frame: upto 2yrs ]
  4. comparison of quality of life [ Time Frame: upto 2years ]

Other Outcome Measures:
  1. comprehensive geriatric assessment [ Time Frame: baseline ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02114359


Contacts
Contact: In Sil Choi, M.D., Ph.D. 82-10-9137-3883 hmoischoi@hanmail.net

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang, Korea, Republic of, 431-796
Contact: ZANG, M.D.       fhdzang@hallym.ac.kr   
Principal Investigator: ZANG, M.D.         
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: LEE, M.D.         
Principal Investigator: LEE, M.D.         
Chungbuk National University Hospital Not yet recruiting
Cheongju, Korea, Republic of, 361-711
Contact: HAN, M.D.         
Principal Investigator: HAN, M.D.         
Kyungpook National University Medical Center Recruiting
Daegu, Korea, Republic of, 702-210
Contact: KIM, M.D.         
Principal Investigator: KIM, M.D.         
Yeongnam University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: KOH, M.D.         
Principal Investigator: KOH, M.D.         
National Cancer Center Recruiting
Goyang, Korea, Republic of, 410-769
Contact: PARK, M.D.       youngiee@dreamwiz.com   
Principal Investigator: PARK, M.D.         
Gachon University Gil Medical Center Not yet recruiting
Incheon, Korea, Republic of, 400-713
Contact: SIM, M.D.         
Principal Investigator: SIM, M.D.         
Inje University Pusan Paik Hospital Recruiting
Pusan, Korea, Republic of, 614-735
Contact: KIM, M.D.         
Principal Investigator: KIM, M.D.         
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463-707
Contact: LEE, M.D.       hmodoctor@hanmail.net   
Principal Investigator: LEE, M.D.         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: RYU, M.D.         
Principal Investigator: RYU, M.D.         
SMG-SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Contact: CHOI, M.D.         
Principal Investigator: CHOI, M.D.         
Inje University Sanggye Paik Hospital Recruiting
Seoul, Korea, Republic of
Contact: SOHN, M.D.         
Principal Investigator: SOHN, M.D.         
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of
Contact: KOO, M.D.         
Principal Investigator: KOO, M.D.         
The Catholic University of Korea Uijeongbu St. Mary's Hospital Recruiting
Uijeongbu, Korea, Republic of
Contact: KO, M.D.         
Principal Investigator: KO, M.D.         
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Health & Welfare, Korea
Korean Cancer Study Group
Investigators
Principal Investigator: IN SIL CHOI, M.D., Ph.D. SMG-SNU Boramae Medical Center

Publications:

Responsible Party: In Sil Choi, Clinical Associate Professor, Department of Internal Medicine, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier: NCT02114359     History of Changes
Other Study ID Numbers: 20140113/16-2014-9/021
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by In Sil Choi, SMG-SNU Boramae Medical Center:
gastric cancer, elderly, chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Cisplatin
Capecitabine
Fluorouracil
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs