Study comparing the Efficacy and Safety of FOLFIRINOX ( Fluoropyrimidine, Oxaliplatin and Irinotecan) as Chemotherapy regimen For Resectable Gastric Or Gastroesophageal Junction Cancer to ECF (Cisplatin, Epirubicin and Fluoropyrimidine) as chemotherapy regimen which is the standard treatment

Phase 1

Recruiting

• Conditions: Resectable gastroesophageal junction adenocarcinoma; Resectable gastric adenocarcinoma.; Cancer - Oesophageal (gullet); Cancer - Stomach

• Registration Number: ACTRN12616001112459
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

1. Patients more than 18 years age and less than 80 years of age
2. Patients with cytological or histological confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
3. Able to sign Informed Consent
4. World Health Organization (WHO) Performance Status of less than 1
5. Localised gastric cancer or gastroesophageal junction adenocarcinoma considered for curative radical gastrectomy. Eligible patients will have more than or equal to T2 gastric cancer and/ or Siewert III GOJ cancer (cancer of the cardia)
6. Patients must have the following laboratory values:
Hematologic:
Absolute Neutrophil Count (ANC) more than or equal to 1.5x109/L
Hemoglobin (Hgb) more than or equal to 9 g/dl
Platelets (plt) more than or equal to 100x109/L

Biochemistry:
Potassium within normal limits
Total calcium (corrected for serum albumin) and Phosphorus within normal limits
Adequate liver function defined as:
AST/SGOT and ALT/SGPT less than or equal to 1.5 x Upper Limit of Normal (ULN) if AP more than 2.5 ULN
Serum bilirubin less than or equal to 1.5 x ULN
Adequate Kidney function test : Serum creatinine less than or equal to 1.5 x ULN or creatinine clearance more than or equal to 50 ml/min on standard Cockcroft-Gault Equation

Exclusion Criteria

1. Patients who had previously received cytotoxic chemotherapy or radiotherapy for gastric cancer
2. Uncontrolled cardiac disease
3. Stage 4 disease including peritoneal metastases
4. A history of another major cancer, active infection, chronic diarrhoea, unacceptable blood tests either haematological or biochemistry
5. Patients who are pregnant or breast-feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS). Progression-free survival (PFS) is the time from the date of randomization to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.[Post completion of all chemotherapy cycles after surgery, patients will be followed clinically every 3 months and will have surveillance CT scan at 3, 6, 12, 24 and 36 months or as clinically indicated to monitor for PFS.]