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TRIALS OPEN TO PATIENT RECRUITMENT


The clinical trials listed in this section are open to patient recruitment. For each trial, an overview of the study design is provided together with a brief explanation of the trial objectives. A more detailed overview is available in the Members Area.

  1. Adjuvant Colorectal Cancer | QUASAR 2
  2. Metastatic Colorectal Cancer | SUPER
  3. Gastrointestinal Stromal Cancer | REGISTER
  4. Rectal Cancer | PETACC 6
  5. Oesophago-Gastric Cancer | ATTAX 3
  6. Operable Gastric | TOP GEAR
  7. GIST Surgical study |SURGIST
  8. Pancreas Cancer | LAP07
  9. Colorectal Cancer - SCOT
  10. Rectal Cancer | A La CaRT

1.Adjuvant Colorectal Cancer | QUASAR 2 - Click for Trial Schema

Multi-centre International Study of capecitabine +/- bevacizumab as adjuvant treatment of colorectal cancer.

QUASAR 2 uses a new combination for adjuvant therapy: an oral chemotherapy drug (capecitabine) and a molecularly targeted therapy (bevacizumab), to define whether this is superior in efficacy and less in toxicity than capecitabine alone.

Principal Investigators
Dr Eva Segelov Medical Oncologist St Vincent's Hospital, NSW

Supported by
Roche Products P/L

2. Metastatic Colorectal Cancer | SUPER

A randomised phase III multicentre study evaluating the role of palliative resection of the primary tumour in patients with metastatic colorectal cancer.
This randomised phase III trial investigates if surgical resection of the primary tumour in patients with stage IV colorectal cancer decreases intestinal complications and improves overall survival and quality of life.

Principal Investigators
Dr Cameron Platell, St John of God Hospital, WA
Dr Niall Tebbutt, Austin Health, Melbourne

Supported by
Colorectal Surgical Society of Australia and New Zealand, NHMRC Clinical Trials Centre and Australasian Gastro-Intestinal Trials Group

3.Gastrointestinal Stromal Cancer | REGISTER - Click for Trial Schema

A Phase II, open-label, multicentre, dose escalation trial of imatinib followed by nilotinib in patients who have newly diagnosed, inoperable, gastrointestinal stromal tumour.

This is a Phase II, open label, multicentre study evaluating imantinib dose escalation followed by nilotinib after progressive disease, according to stratification into exon 11 and non-exon 11/WT mutational status. The functional response to therapy, as determined by FDG-PET, will be correlated with pharmacokinetics after administration.

Principal Investigators
Dr. Jayesh Desai Royal Melbourne Hospital, Vic

4.Rectal Cancer | PETACC 6 - Click for Trial Schema

A study of preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer.

The PETACC 6 study is an EORTC-led open-label, randomised, multi-national, two-arm phase III study investigating whether the addition of oxaliplatin to preoperative fluoropyrimidine-based chemoradiation and postoperative fluoropyrimidine-based chemotherapy improves disease-free survival in locally.

Principal Investigators
Dr Timothy Price Medical Oncologist Queen Elizabeth Hospital, SA

5.Oesophago-Gastric Cancer | ATTAX 3

An advanced oesophago-gastric cancer with weekly docetaxel, cisplatin, fluoropyrimidine (w/TCF) plus or minus panitumumab in advanced oesophago-gastric cancer.

The ATTAX3 study is a randomised, phase II study comprising two separate components. Patients with advanced oesophago-gastric cancer will be randomised to receive chemotherapy only (wTCF/X) or chemotherapy plus panitumumab. The study will evaluate the objective tumour response rate of these treatment regimes.

Principal Investigator
Dr Niall Tebbutt, Austin Health, Melbourne

6.Operable Gastric | TOP GEAR

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

The primary study objective is to investigate whether preoperative chemoradiotherapy leads to improved survival in comparison with preoperative chemotherapy in patients undergoing adequate surgery (D1 dissection) for resectable gastric cancer.

Principal Investigators
A/Prof Trevor Leong, Radiation Oncologist, Peter MacCallum Cancer Centre


7.GIST Surgical study | SURGIST

A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.

The GIST Surgical study is an EORTC-led study. It will assess the impact of adjuvant surgery on progression-free survival time in patients with GIST who have experienced complete response, partial response or stable disease following 6 - 12 months of treatment with imatinib. Patients will be randomized to receive surgery or not.

Principal Investigators
Professor Bruce Mann, Royal Melbourne Hospital.
Dr Alessandro Gronchi, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano, Italy

8.Pancreas Cancer | LAP07

A randomised multicentre phase III study in patients with locally advanced adenocarcinoma of the pancreas; gemcitabine with or without chemoradiotherapy and with or without erlotinib.

For patients with pancreatic cancer, surgery to remove the entire tumor is the only potentially curative treatment. However, many patients have tumors that are localized but cannot be removed by surgery because the tumor is near a large blood vessel or joined to the stomach or bowel. These patients are generally treated with chemotherapy. Even with chemotherapy, their prognosis is very poor. It is not clear to doctors and researchers whether additional treatment with radiotherapy is beneficial. It is also unknown whether the newer targeted (antibody) type treatments are useful.

LAP07 is an international trial led by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) a French collaborative research group. It will test whether a combination of chemotherapy and radiotherapy is better than chemotherapy alone in patients with localized but inoperable pancreatic cancer. It will also investigate the possible role of the newer antibody type drugs. Investigators will assess whether survival is improved with the addition of radiotherapy and the newer drugs.

Principal Investigator
Conjoint Professor David Goldstein, Medical Oncologist, Prince of Wales Hospital, NSW

9.Colorectal Cancer - SCOT

Short Course Oncology Therapy - A Study of Adjuvant Chemotherapy in Colorectal Cancer.

An international, open-label randomised, two-arm phase III non-inferiority trial investigating a shortened duration of treatment for patients with high-risk stage II/III colorectal cancer.

The SCOT study aims to definitively answer the question of whether 12 weeks of adjuvant chemotherapy using a 5FU/oxaliplatin regimen is as effective as 24 weeks of the identical treatment in reducing cancer recurrence. In addition, if SCOT can establish equivalent efficacy with a shortened duration of adjuvant treatment, it will significantly decrease the financial burden of adjuvant treatment on a population basis, and produce vast benefits in terms of short and long term morbidity.

Principal Investigators
Doctor Andrew Haydon, Medical Oncologist, The Alfred Hospital, VIC

10.Rectal Cancer | A La CaRT

A phase III prospective randomised trial comparing laparoscopic-assisted resection versus open resection for rectal cancer.
The A La CaRT study is a rsndomised phase III trial designed to determine if laparoscopic-assisted resection is a safe, effective and feasible approach for patients with resectable rectal
cancer.

Principal Investigator
Dr Andrew Stevenson, Royal Brisbane Hospital

Supported by
Colorectal Surgical Society of Australia and New Zealand, NHMRC Clinical Trials Centre and Australasian Gastro-Intestinal Trials Group