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

NCT02289547 | Unknown Phase 3

• 1 other identifier: CMCGA1 Trial
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 8

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 .

Conditions

Stomach Neoplasms

Keywords

chemotherapy; stomach neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression free survival

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

  From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years

Secondary Outcomes (3)

• Overall survival

  From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years

• quality of life in patients measured by QLQ-c30 and STO-22

  From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years

• Toxicity profile of each patients measured by NCI-CTCAE ver 4.0

  From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years

Study Arms (2)

Group A

NO INTERVENTION

observational arm

Group B

EXPERIMENTAL

arm of capecitabine maintenance treatment

Drug: Capecitabine

Interventions

Capecitabine DRUG

maintenance capecitabine therapy after six cycles of XELOX

Also known as: Xeloda

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (8)

St. Vincent's Hospital

Suwon, Gyeonggi-do, 442-723, South Korea

RECRUITING

Buchon St. Mary's Hospital

Buchon, South Korea

RECRUITING

Daejeon St. Mary's Hospital

Daejeon, South Korea

RECRUITING

Incheon St. Mary's Hospital

Incheon, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

St. Mary's Hospital

Seoul, South Korea

RECRUITING

Bundang Seoul National hospital

Sungnam, South Korea

RECRUITING

Ujeongbu St. Mary's Hospital

Ujeongbu, South Korea

RECRUITING

Related Publications (6)

• 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.

  PMID: 15856038 BACKGROUND

• 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.

  PMID: 17522863 BACKGROUND

• 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.

  PMID: 20676676 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

• 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 GJ, Kim H, Cho SS, Park HS, An HJ, Woo IS, Byun JH, Hong JH, Ko YH, Sun S, Won HS, Jin JY, Park JC, Kim IH, Roh SY, Shim BY. A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation. J Gastric Cancer. 2023 Apr;23(2):315-327. doi: 10.5230/jgc.2023.23.e16.

  PMID: 37129155 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine

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; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Byoungyong Shim, M.D.,Ph.D

  St.Vincent's Hospital of The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Young Seon Hong, M.D.,Ph.D

  Seoul St. Mary's Hopital of The Catholic Univerisity of Korea

  PRINCIPAL INVESTIGATOR

• In Sook Woo, M.D.,Ph.D

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

  PRINCIPAL INVESTIGATOR

• Jae Ho Byun, M.D.,Ph.D

  Incheon St. Mary's Hopital of The Catholic Univerisity of Korea

  PRINCIPAL INVESTIGATOR

• Cuk Jin Lee, M.D.,Ph.D

  Bucheon St. Mary's Hopital of The Catholic Univerisity of Korea

  PRINCIPAL INVESTIGATOR

• Ji Chan Park, M.D.,Ph.D

  Daejeon St. Mary's Hopital of The Catholic Univerisity of Korea

  PRINCIPAL INVESTIGATOR

• Yoon Ho Ko, M.D.,Ph.D

  Ujeongbu St. Mary's Hopital of The Catholic Univerisity of Korea

  PRINCIPAL INVESTIGATOR

• Keun Wook Lee, M.D.,Ph.D

  Bundang Seoul National Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Byoungyong Shim, M.D., Ph.D

CONTACT

82312497126; shimby@catholic.ac.kr

Ho Jung An, M.D.

CONTACT

82312497135; meicy@catholic.ac.kr

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: Associated professor

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 13, 2014
• Study Start: May 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: June 14, 2017

Record last verified: 2017-06

Locations

KR (8)