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

NCT02114359 | Completed Phase 3 DMC

• 1 other identifier: 20140113/16-2014-9/021
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 14

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.

Conditions

Gastric Cancer

Keywords

gastric cancer, elderly, chemotherapy

Outcome Measures

Primary Outcomes (1)

• comparison of overall survival

  upto 3years

Secondary Outcomes (4)

• 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 Outcomes (1)

• comprehensive geriatric assessment

  baseline

Study Arms (2)

Platinum/fluoropyrimidine combination chemotherapy

EXPERIMENTAL

Drug: Capecitabine/cisplatin; Drug: S-1/cisplatin; Drug: Capecitabine/oxaliplatin; Drug: 5-fluorouracil/oxaliplatin

Fluoropyrimidine monochemotherapy

ACTIVE COMPARATOR

Drug: Capecitabine; Drug: S-1; Drug: 5-fluorouracil

Interventions

Capecitabine/cisplatin DRUG

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

Platinum/fluoropyrimidine combination chemotherapy

S-1/cisplatin DRUG

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

Platinum/fluoropyrimidine combination chemotherapy

Capecitabine/oxaliplatin DRUG

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

Platinum/fluoropyrimidine combination chemotherapy

5-fluorouracil/oxaliplatin DRUG

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

Platinum/fluoropyrimidine combination chemotherapy

Capecitabine DRUG

Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr \<60ml/min, 1000mg/m2 po bid)

Fluoropyrimidine monochemotherapy

S-1 DRUG

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

Fluoropyrimidine monochemotherapy

5-fluorouracil DRUG

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

Fluoropyrimidine monochemotherapy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Metastatic or recurrent, histologically confirmed adenocarcinoma of stomach - Previously untreated patients, including patients with previous adjuvant chemotherapy completed more than 6 months
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Health & Welfare, Korea: collaborator
• Korean Cancer Study Group: collaborator

Study Sites (14)

Hallym University Sacred Heart Hospital

Anyang, 431-796, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, 361-711, South Korea

Location

Kyungpook National University Medical Center

Daegu, 702-210, South Korea

Location

Yeongnam University Medical Center

Daegu, South Korea

Location

National Cancer Center

Goyang, 410-769, South Korea

Location

Gachon University Gil Medical Center

Incheon, 400-713, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, 614-735, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Location

Related Publications (9)

• 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.

  PMID: 8508349 BACKGROUND

• 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.

  PMID: 12506170 BACKGROUND

• 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.

  PMID: 10894863 BACKGROUND

• 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.

  PMID: 1801881 BACKGROUND

• 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.

  PMID: 19153121 BACKGROUND

• 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.

  PMID: 18282805 BACKGROUND

• 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.

  PMID: 18172173 BACKGROUND

• 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.

  PMID: 18665164 BACKGROUND

• 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.

  PMID: 10765119 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Cisplatin; S-1 plus cisplatin; XELOX; Fluorouracil; Oxaliplatin; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• IN SIL CHOI, M.D., Ph.D.

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Department of Internal Medicine

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 15, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

KR (14)