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Closed (no longer recruiting)Last updated: 22 April 2024

TOP GEAR: This phase II/III trial is comparing preoperative chemradiotherapy with preoperative chemotherapy for patients with resectable gastric cancerA randomised phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer (Other IDs: TROG 08.08, AG0407GR).

Clinical summary

Summary

The main treatment for stomach cancer is surgery. However, even with surgery there is still a risk that the cancer may come back if no further treatment is given. Over the last 5 years, 2 large international studies have shown that giving additional treatment with radiotherapy and chemotherapy may improve the chances of curing patients with stomach cancer. Firstly, a large British study called MAGIC has shown that giving chemotherapy BEFORE and AFTER surgery is better than just surgery alone. Secondly, a large US study called INT0116 has shown that giving combined chemotherapy and radiotherapy together (chemoradiation) AFTER surgery is better than surgery alone. The purpose of this study is to compare these 2 treatments to determine which is better. Unlike in the US study, in this study we will be giving chemoradiation BEFORE surgery (preoperative treatment), rather than AFTER surgery (postoperative treatment). This is because we know from studies in other types of cancers that preoperative treatment is better than postoperative treatment. In addition, preoperative treatment also produces fewer side effects so that patients are more likely to complete the planned treatment. The main aim of this study is therefore to determine if preoperative chemoradiation is more effective than preoperative chemotherapy alone for patients with localised stomach cancer who are going to be treated with surgery. We will also be looking at the side effects of the two treatment combinations.

Conditions

This trial is treating patients with Stomach (Gastric) and Gastro-Oesophageal Junction Cancers

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18 - 75

Phase

II/III

Trial Acronym

TOP GEAR

More information

Trial Identifiers

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Trial sponsor

Australasian Gastro-Intestinal Trials Group (AGITG)

Scientific Title

A randomised phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer (Other IDs: TROG 08.08, AG0407GR).

Eligibility

Inclusion

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

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.

Inclusion

  • Your cancer has not spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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