Observational Study of Perioperative Chemotherapy in Gastric Cancer

NCT01633203 | Completed

• 1 other identifier: GOCCHI 2009-01
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the efficacy and toxicity of perioperative chemotherapy with Epirubicin + Cisplatin + Capecitabine (ECX) in routine clinical practice in a network of public hospitals in Santiago, Chile.

Conditions

Gastric Cancer

Keywords

gastric cancer; combination chemotherapy; HER-2 gene; quality of life

Outcome Measures

Primary Outcomes (1)

• Rate of downstaging

  To determine the rate of downstaging of locally advanced cT3-4 and/or N+ gastric carcinomas after 3 cycles of preoperative chemotherapy with ECX

  through study completion, an average of 3 months

Secondary Outcomes (10)

• Rate of adverse events

  through study completion, an average of 6 months

• Clinical response after three cycles of preoperative ECX

  through study completion, an average of 6 months

• To evaluate the surgical morbidity after three cycles of preoperative CT

  through study completion, an average of 1 year

• To evaluate the surgical mortality after three cycles of preoperative CT

  through study completion, an average of 1 year

• progression free survival

  through study completion, an average of 2 years

Study Arms (1)

locally advanced gastric cancer

Patients with resectable, locally advanced cT3-4 and/or N+ gastric carcinoma treated with 3 perioperative epirubicin cisplatin capecitabine polychemotherapy

Drug: epirubicin + cisplatin + capecitabine polychemotherapy

Interventions

epirubicin + cisplatin + capecitabine polychemotherapy DRUG

EPIRUBICIN (LKM)at a dose of 50 mg/m2 over 15 minutes is administered every 21 days. CISPLATIN (LKM) at a dose of 60 mg/m2 over 4 hours is administered every 21 days. Patients must receive standardized hydration per protocol. CAPECITABINE (Xeloda®) at a dose of 625 mg/m2 BID (i.e. 1250 mg/m2/day) 30 minutes after meals from day 1 to day 21 of every cycle of chemotherapy. Antiemetic therapy: * Dexamethasone 8 mg IV and Ondansetron (LKM) 8 mg IV o Granisetron (Kytril®) prior to chemotherapy * Rescue Ondansetron (LKM) 8 mg IV will be given during 24-hour hospitalization in case of emesis * Symptomatic antiemetic therapy with thiethylperazine will be prescribed. Loperamide will be prescribed in case of diarrhea.

locally advanced gastric cancer

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Current diagnosis of T3-4 and/or N+ M0 (according to staging system of the American Joint Committee on Cancer 2002) resectable gastric cancer. The resectability has to be confirmed by a surgical oncologist and/or Oncological Committee.

You may qualify if:

• Histologically proven invasive carcinoma
• Age \> 18 years.
• ECOG performance status 0 or 1.
• Hemoglobin \> 9 g/dL
• Absolute neutrophil count \> 1.5 x 109/L
• Platelet count \> 100 x 109/L
• Creatinine \< 1.5 ULN
• Creatinine clearance \> 60 mL/min
• Serum bilirubin \< 1.5 x ULN
• AST \< 2.5 x ULN
• Women of child bearing potential: must agree to use an effective contraceptive method.
• Signed informed consent.

You may not qualify if:

• ECOG \> 2.
• Pre-existing diarrhea uncontrolled with supportive care.
• Inability to swallow Xeloda tablets.
• History of mild-to-moderate renal insufficiency (creatinine clearance \< 45 mL/min).
• Signs or symptoms of clinically significant hepatic dysfunction (bilirubin \> 1.5 ULN, FA \> 2.5 ULN, albumin \< 2,5 g/dL).
• Significant cardiac dysfunction (LVEF \< LLN)
• Presence of distant metastasis, including clinical signs of peritoneal carcinomatosis
• Symptomatic gastric retention or severe dysphagia with a caloric intake of \< 1500 kcal/day
• Histology of lymphoma, GIST or neuroendocrine tumor
• Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use an effective method of contraception.
• Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include congestive heart failure of Class III or IV of the NYHA classification, infection requiring parental or oral treatment, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.

Sponsors & Collaborators

• Grupo Oncologico Cooperativo Chileno de Investigation: lead

Study Sites (1)

Instituto Nacional del Cáncer

Santiago, RM, 8380455, Chile

Location

Related Publications (3)

• Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.

  PMID: 16822992 BACKGROUND

• Okines AFC, Norman AR, McCloud P, Kang YK, Cunningham D. Meta-analysis of the REAL-2 and ML17032 trials: evaluating capecitabine-based combination chemotherapy and infused 5-fluorouracil-based combination chemotherapy for the treatment of advanced oesophago-gastric cancer. Ann Oncol. 2009 Sep;20(9):1529-1534. doi: 10.1093/annonc/mdp047. Epub 2009 May 27.

  PMID: 19474114 BACKGROUND

• Garcia CC, Benavides CC, Apablaza SP, Rubilar PO, Covacevich SR, Penaloza PM, Guerra JC, Horwitz BZ, Domancic PH, Bustamante R M, Romero S C. [Surgical treatment of gastric cancer: results in 423 cases]. Rev Med Chil. 2007 Jun;135(6):687-95. Epub 2007 Aug 22. Spanish.

  PMID: 17728893 BACKGROUND

Related Links

• Homepage of the Chilean Cooperative Group for Oncological Research

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Epirubicin; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Bettina G Muller, MD

  Grupo Oncologico Cooperativo Chileno de Investigation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2012
• First Posted: July 4, 2012
• Study Start: August 1, 2010
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 24, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: December 2019, for 10 years
• Access Criteria: The investigators who wish to use the data should submit the protocol (approved by an IRB) and the request to access the database to GOCCHI (admin@gocchi.org)

Locations

CL (1)