• OMEGCA
    Share

Trial Status

Open / Translational Research Studies

Cancer Type

Stomach Cancer, Oesophageal Cancer

Protocol Title

OMEGCA: Multi-Omics Evaluation of Peritoneal Fluid in Gastroesophageal Cancer – A prospective trial to develop a sensitive assay to detect clinically occult peritoneal metastases.

Purpose of the Study

The staging of stomach and oesophageal cancer is crucial for determining whether this disease is curable or not and allows patients and doctors to select the best treatment approach. Stomach and oesophageal cancers have a high likelihood of spreading to the abdominal cavity (peritoneum). Once the cancer has spread to the peritoneum, the disease is currently considered incurable. Unfortunately, despite the best tests available, our ability to accurately stage the peritoneum is inadequate. This means that many patients are being offered aggressive treatments with significant side effects that offer potentially little benefit. An accurate test to stage the peritoneum is urgently needed to personalise treatment to the individual and avoid over-treating these patients.

The OMEGCA study will examine cancer-derived DNA in samples (“peritoneal washings”) from 200 patients to potentially develop a new, more accurate way of detecting cancer spread to the peritoneum. We hope that a new test like this will help inform clinical decision-making and guide cancer treatment in these patients to maximise benefit and reduce harm.

Eligibility Criteria

Inclusion Criteria

  • All patients ≥18 years-of-age with
  • Gastric adenocarcinoma
  • Gastroesophageal junction adenocarcinoma
  • Undergoing staging laparoscopy and peritoneal lavage cytology

Exclusion Criteria

  • Strictly Oesophageal cancer
  • Non-adenocarcinoma malignancy
  • Distant organ disease on CT and PET/CT
  • Non-regional nodal disease on CT and PET/CT
  • Peritoneal carcinomatosis on CT and PET/CT
  • Performance status ECOG ≥3
  • Age <18 years
  • Undergoing emergency surgery
  • Non-consenting patients
  • Non-curative/palliative-intent treatment

CONTACT EMAIL

agitg@gicancer.org.au

Study Chair

Dr David Liu
A/Prof Nicholas Clemons

DETAILED INFORMATION AVAILABLE

More detailed information available online at the Australian New Zealand Clinical Trial Registry (ANZCTR)

Funding

2023 AGITG Innovation Grant
Victorian Cancer Agency

Participating Centres

South Australia
Royal Adelaide Hospital
Queen Elizabeth Hospital
Flinders Medical Centre
Victoria
Northern Hospital
Box Hill Hospital/Eastern Health
Sunshine Hospital/Western Health
St Vincents Hospital, Melbourne
Royal Melbourne Hospital
Peter MacCallum Cancer Centre
Monash Medical Centre
Austin Health

Trial Status

Open / Translational Research Studies

Cancer Type

Stomach Cancer, Oesophageal Cancer

If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.

Protocol Title

TOP GEAR: Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma

A randomised II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer.

Publication Reference

Leong T, Smithers BM, Haustermans K, Michael M, Gebski V, Miller D, Zalcberg J, Boussioutas A, Findlay M, O’Connell RL, Verghis J, Willis D, Kron T, Crain M, Murray WK, Lordick F, Swallow C, Darling G, Simes J, Wong R. TOPGEAR: a randomized, phase III trial of perioperative ECF chemotherapy with or without preoperative chemoradiation for resectable gastric cancer: interim results from an international, intergroup trial of the AGITG, TROG, EORTC and CCTG. Annals of Surgical Oncology. Published online 25 Mar 2017.

Leong T, Smithers BM, Michael M, Gebski V, Boussoutias A, Miller D, Simes J, Zalcberg J, Hausterman K, Lordick F, Schuhmacher C, Swallow C, Darling G, Wong R. TOPGEAR: a randomised phase III trial of perioperative ECF chemotherapy versus preoperative chemoradiation plus perioperative ECF chemotherapy for resectable gastric cancer (an international, intergroup trial of the AGITG/TROG/EORTC/NCIC CTG). BMC Cancer 2015; 15: 532.

Conference Presentation Reference

Goldstein D, Fawcett J, Bridgewater JA, Choti M, Wilson K, Gebski V, Aiken C, Eminton Z, Falk S, Stanton L, Primrose JN. Feasibility of trials to assess safety and toxicity of peri-operative and post-operative adjuvant therapy for hepatic metastases from colorectal cancer. European Cancer Congress 2015; 25-29  Sep 2015; Vienna

Verghis J, Miller D, Smithers BM, Murray WK, Crain M, Leong T. Conducting quality assurance processes in a multimodality treatment study involving chemoradiotherapy and surgery—measuring data integrity in the TOPGEAR trial. ACTA 2015 International Clinical Trials Symposium; 7–10 Oct 2015; Sydney.

Leong T, Smithers M, Michael M, Gebski V, Boussioutas A, Miller D, Zalcberg J, Wong R, Haustermans K. TOPGEAR: An international randomized phase III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer (AGITG/TROG/EORTC/NCIC CTG). American Society of Clinical Oncology Annual Meeting; 1–5 Jun 2012; Chicago.

Aim

The purpose of TOPGEAR is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving pathological complete response (pCR) rates in the first instance, and subsequently overall survival, in patients undergoing adequate surgery (D1+ dissection) for resectable gastric cancer.

Background

Gastric cancer remains a significant global public health problem. Although in developed countries its incidence has dramatically decreased, on a worldwide scale it is still a leading cause of cancer-related deaths. Surgery is the only potentially curative treatment for gastric cancer. Although the survival rates for patients with early stage disease are good, this subgroup of patients constitutes only 20% of those undergoing resection. The majority of patients will have locally advanced or metastatic disease at presentation, which has an extremely poor prognosis. The current five-year survival rate for gastric cancer in Western countries is approximately 20-30%.

An important question that needs to be addressed is whether chemoradiotherapy is superior to chemotherapy alone in the neoadjuvant treatment of resectable gastric cancer.

The interventional arm of TOPGEAR consists of pre-operative chemotherapy, pre-operative chemoradiotherapy, surgery and post-operative chemotherapy. The control arm consists of pre-operative chemotherapy, surgery and post-operative chemotherapy.

The outcome of the trial may contribute to the improvement of survival rates of patients who undergo gastric surgery.

Clinical Trial Design

TOP GEAR is a multicentre, prospective, randomised, stratified, phase II/III clinical trial.

Eligible patients, with resectable adenocarcinoma of the stomach or gastroesophageal junction, will be randomly allocated to one of two treatment groups to receive:

(1) Perioperative chemotherapy alone (control arm). This may comprise 3 pre-operative and 3 post-operative cycles of ECF, ECX or EOX; or 4 pre-operative and 4 post-operative cycles of FLOT. ; or

(2) Perioperative chemotherapy plus preoperative chemoradiation (experimental arm).

In the experimental chemoradiation arm, patients will undergo the following treatment schedule. Patients will receive one of 4 different standard chemotherapy regimens (ECF, ECX, EOX or FLOT) at the discretion of their treating clinician. Patients may receive 2 cycles of ECF, ECX or EOX at three weekly intervals before their operation. Alternatively, they may receive 3 cycles of FLOT at two weekly intervals before their operation. They will have a 2–4 week break between the last chemotherapy treatment and starting chemoradiotherapy. Following chemoradiotherapy, patients should have up to six weeks break between chemoradiotherapy and surgery.Patients will then commence 3 post-operative cycles of ECF, ECX or EOX, or 4 post-operative cycles of FLOT, between 4-10 weeks after surgery.

The acceptable types of resection surgery are a total gastrectomy, subtotal gastrectomy and an oesophago-gastrectomy. There will be three years of follow up.

Patients Recruited

Click here to access the table and view recruitment data on all AGITG open trials:

Open Trial Recruitment Table

Participating Centres

South Australia
Royal Adelaide Hospital
Queen Elizabeth Hospital
Flinders Medical Centre
Victoria
Northern Hospital
Box Hill Hospital/Eastern Health
Sunshine Hospital/Western Health
St Vincents Hospital, Melbourne
Royal Melbourne Hospital
Peter MacCallum Cancer Centre
Monash Medical Centre
Austin Health

Key Eligibility Criteria

Please note that the information below contains only the most important inclusion and exclusion criteria and is not a comprehensive list.

Key inclusion criteria:

  • Adults (18 years or over) with adenocarcinoma of the stomach or gastroesophageal junction confirmed with histological test.
  • Adequate organ function (as defined for the trial)
  • Disease which can be radically treated with radiotherapy
  • 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
  • Negative pregnancy test for women of childbearing potential within seven days of commencing the study.

Key exclusion criteria:

  • Evidence of metastatic disease
  • Prior chemotherapy or radiotherapy
  • Patients with past history of cancer in the 5 years before randomisation (except for 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)
  • Patients with impaired gastro-intestinal absorption
  • Patients medically unfit for cisplatin chemotherapy.

Visit ANZTCR for more detailed information on inclusion/exclusion criteria and eligibility.

Contact Email

topgear@ctc.usyd.edu.au

Principal Investigator

Professor Trevor Leong (Peter MacCallum Cancer Centre, Melbourne VIC)

More Information

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.

Funding

Cancer Australia through The Priority-driven Collaborative Cancer Research Scheme.
Cancer Council Australia.
National Health and Medical Research Council.