Observational Study of Perioperative Chemotherapy in Gastric Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01633203
• Date of registration: 30/06/2012
• Prospective Registration: No
• Primary sponsor: Grupo Oncologico Cooperativo Chileno de Investigation
• Public title: Observational Study of Perioperative Chemotherapy in Gastric Cancer PRECISO
• Scientific title: Prospective Observational Study of Patients With Locally Advanced Gastric Cancer Treated With Perioperative Chemotherapy and Surgery
• Date of first enrolment: August 2010
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01633203
• Study type: Observational

Countries of recruitment

Chile

Contacts

• Name: Bettina G Muller, MD
• Affiliation: Grupo Oncologico Cooperativo Chileno de Investigation

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 19 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Gastric Cancer

Intervention(s)

Drug: epirubicin + cisplatin + capecitabine polychemotherapy

Primary Outcome(s)

Rate of downstaging [Time Frame: through study completion, an average of 3 months]

Secondary Outcome(s)

EORTC QLQ-STO 22 after neoadjuvant chemotherapy and surgery [Time Frame: through study completion, an average of 2 years]

Rate of adverse events [Time Frame: through study completion, an average of 6 months]

To evaluate the surgical mortality after three cycles of preoperative CT [Time Frame: through study completion, an average of 1 year]

To evaluate the surgical morbidity after three cycles of preoperative CT [Time Frame: through study completion, an average of 1 year]

HER 2 expression [Time Frame: through study completion, an average of 1 year]

overall survival [Time Frame: through study completion, an average of 3 years]

Clinical response after three cycles of preoperative ECX [Time Frame: through study completion, an average of 6 months]

compliance with the planned postoperative therapy [Time Frame: through study completion, an average of 1 year]

progression free survival [Time Frame: through study completion, an average of 2 years]

EORTC QLQ-C30 after neoadjuvant chemotherapy and surgery [Time Frame: through study completion, an average of 2 years]

Secondary ID(s)

GOCCHI 2009-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors