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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02114359

Collaborator

Ministry of Health & Welfare, Korea (Other), Korean Cancer Study Group (Other)

111

Enrollment

Locations

Arms

Duration (Months)

7.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

111 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 :

Feb 1, 2014

Actual Primary Completion Date :

Feb 1, 2020

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

comparison of overall survival [upto 3years]

Secondary Outcome Measures

comparison of progression-free survival [upto 2years]
comparison of response rate [upto 2years]
comparison of adverse events [upto 2yrs]
comparison of quality of life [upto 2years]

Other Outcome Measures

comprehensive geriatric assessment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hallym University Sacred Heart Hospital	Anyang	Korea, Republic of	431-796
2	Inje University Haeundae Paik Hospital	Busan	Korea, Republic of
3	Chungbuk National University Hospital	Cheongju	Korea, Republic of	361-711
4	Kyungpook National University Medical Center	Daegu	Korea, Republic of	702-210
5	Yeongnam University Medical Center	Daegu	Korea, Republic of
6	National Cancer Center	Goyang	Korea, Republic of	410-769
7	Gachon University Gil Medical Center	Incheon	Korea, Republic of	400-713
8	Inje University Pusan Paik Hospital	Pusan	Korea, Republic of	614-735
9	Seoul National University Bundang Hospital	Seongnam	Korea, Republic of	463-707
10	Asan Medical Center	Seoul	Korea, Republic of	138-736
11	SMG-SNU Boramae Medical Center	Seoul	Korea, Republic of	156-707
12	Inje University Sanggye Paik Hospital	Seoul	Korea, Republic of
13	Kangbuk Samsung Hospital	Seoul	Korea, Republic of
14	The Catholic University of Korea Uijeongbu St. Mary's Hospital	Uijeongbu	Korea, Republic of