TOP GEAR: Trial of Preoperative Therapy for Gastric and Esophagogastric Junction AdenocarcinomaA randomised phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer

Phase 2

Active, not recruiting

• Conditions: Resectable Gastric Cancer; Cancer - Stomach

• Registration Number: ACTRN12609000035224
• Lead Sponsor: Australasian Gastro-Intestinal Trials Group (AGITG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-19
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 574

Inclusion Criteria

1. Histologically proven adenocarcinoma of the stomach or gastroesophageal junction that is:
a. Stage IB (T1N1 only, T2N0 not eligible) – IIIC, i.e. T3 – T4 and/or N +ve, according to AJCC 7th edition.
b. Considered operable following initial staging investigations (surgeon believes that an R0 resection can be achieved).
(Gastroesophageal tumours are defined as tumours that arise in the cardia or at the GEJ that do not involve more than 2cm of the lower esophagus, i.e. Siewert Type II and Siewert Type III)
2. Age >= 18 years
3. ECOG performance status 0-1
4. Adequate organ function defined as follows:
Bone marrow: Haemoglobin >= 90 g/L
Absolute neutrophil count (ANC) >= 1.5 x 109 /L
White blood cell count >= 3 x 109 /L
Platelet count >= 100 x 109 /L
Hepatic: Serum bilirubin <= 1.5 x ULN
AST and/or ALT <= 3.0 x ULN
Renal: Serum creatinine <= 0.150 mmol/L, and calculated creatinine clearance >= 50mL/min.
5. Disease which can be radically treated with radiotherapy to 45 Gy with standard fractionation
6. Any patient with a history of ischaemic heart disease and abnormal ECG, or who is over 60 years of age should have a pre-treatment evaluation of cardiac function with a MUGA scan or echocardiogram. Patients will only be included if the left ventricular ejection fraction is >= 50%.
7. Written informed consent obtained before randomization.
8. Negative pregnancy test for women of childbearing potential within 7 days of commencing study treatment. Males and females of reproductive potential must agree to practice adequate contraceptive measures

Exclusion Criteria

None of the following must apply:
1. Evidence of metastatic disease
2. Prior chemotherapy or radiotherapy
3. Patients with a past history of cancer in the 5 years before randomization except for the following. Patients with squamous or basal cell carcinoma of the skin that has been effectively treated, and patients with carcinoma in situ of the cervix that has been treated by operation only are eligible, even if they were diagnosed and treated within the 5 years before randomization.
4. Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled.
5. Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures.
6. Cardiac failure and other contraindications to epirubicin.
7. Patients with impaired gastrointestinal absorption for whatever reason.
8. Patients medically unfit for cisplatin chemotherapy due to one or more of the following reasons:
a. Clinically significant sensori-neural hearing impairment (audiometric abnormalities without corresponding clinical deafness will not be regarded as a contraindication to cisplatin)
b. Severe tinnitus
c. Renal impairment (GFR<= 50ml/min)
d. Peripheral neuropathy => grade 2
e. Inability to tolerate intravenous hydration e.g due to cardiac disease
f. Co-morbidities (based on clinical judgement by the investigator) that in the view of the investigator would preclude the safe administration of cisplatin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival[ Overall survival will be measured from date of patient entry onto the study to date of death from any cause. Following completion of study every 6 months from year 2 assessment until 5 years (date to be calculated from last day of last post-op ECF (or ECX) cycle)]