None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the efficacy and safety of FOLFIRINOX chemotherapy for the treatment of gastric or gastroesophageal junction cancer prior to surgery. Who is it for? You may be eligible to participate in this trial if you are aged 18 to 80 years and have been diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma for which you are scheduled to undergo radical gastrectomy. Study details The first ten participants enrolled in this trial will all receive FOLFIRINOX chemotherapy prior to surgery. If six of these participants are able to undergo surgery as planned, then all remaining participants enrolled in this trial will then be randomly allocated computer generated software to receive either FOLFIRINOX chemotherapy prior to surgery, or to receive standard care ECF chemotherapy prior to surgery. Participants in the FOLFIRINOX group will receive a 46 hours continuous infusion of chemotherapy once every 2 weeks for 12 weeks. Participants in the ECF group will receive a 46 hours continuous infusion of chemotherapy every 3 weeks for 12 weeks before surgery and 3 cycles after surgery which will be also be every 3 weeks for 12 weeks . It is anticipated that all participants will then undergo surgery within 3-6 weeks. Participants will be assessed for side effects and followed-up for up to five years to assess disease progression and survival. It is hoped that the findings of this trial will establish whether FOLFIRINOX chemotherapy may be a safe and effective alternative to ECF chemotherapy for the pre-surgical treatment of gastric or gastroesophageal junction cancer.
Interventions
This trial is conducted in 2 steps
In the pilot phase of the trial which is to test for feasability, first 10 patients will be treated with FOLFIRINOX. The feasibility will be defined as the ability of 6 out of 10 pilot patients to undergo curative gastric resection within 18 weeks of starting FOLFIRINOX.
Then we will proceed to phase II of trial where patients will be randomised in 1:1 ratio to standard ECF chemotherapy versus FOLFIRINOX.
Patients will be adequately staged using CT scan ches
This trial is conducted in 2 steps In the pilot phase of the trial which is to test for feasability, first 10 patients will be treated with FOLFIRINOX. The feasibility will be defined as the ability of 6 out of 10 pilot patients to undergo curative gastric resection within 18 weeks of starting FOLFIRINOX. Then we will proceed to phase II of trial where patients will be randomised in 1:1 ratio to standard ECF chemotherapy versus FOLFIRINOX. Patients will be adequately staged using CT scan chest/ abdomen/ pelvis, Echo, lung functions and laparoscopy to rule out metastatic disease and assess fitness for curative gastric resection. The patients will be discussed at the Statewide Upper GI MDT. Patients will be consented and have PICC or PORT inserted prior to start of treatment. Folfirinox Chemotherapy will be administered for six cycles preoperatively (3 months). A typical cycle will consist of oxaliplatin 85 mg/m2 ; irinotecan 150 mg/m2; leucovorin 50mg. These will be given as a bolus simultaneously followed by 5 FU 2400 mg/m2. 5FU will be a 46-hour continuous infusion, Each cycle is given once every 2 weeks. Patients will be provided with adequate anti emetics and supportive medications as per the institution preference. Growth factors and prophylactic antibiotics are not mandated. Before each cycle of chemotherapy, a complete blood count, renal and liver function tests will be checked. Patients will be reviewed and assessed every two weeks in the FOLFIRINOX arm to monitor their treatment. After completing all prescribed cycles of chemotherapy, patients will undergo restaging with CT scan and endoscopy prior to surgery. A minimum interval of 3 weeks will be mandated from last day of chemotherapy to surgery. Majority of the patients will have surgical resection within 3-6 weeks of completing chemotherapy. Post surgery, patients will be followed clinically every 3 months and will have surveillance CT scans at 3, 6, 12, 24 and 36 months or as clinically indicated.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Outcome results
None listed