TRIALS IN FOLLOW UP

The clinical trials listed in this section are closed to new 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. Colon Cancer | NSABP CO6
2. Stage 11 & 111 Colon Cancer | NSABP CO7
3. Advanced GIST | AG0102 GIST / EORTC 62005
4. Liver Metastases (Colorectal) | EORTC 40983
5. European Study of Adjuvant Chemotherapies in Resectable Pancreatic Cancer (ESPAC) 3
6. Adjuvant GIST | EORTC 62024
7. Metastatic Colorectal Cancer | CO.20
8. Adjuvant Colorectal Cancer | QUASAR 2
9. Rectal Cancer | PETACC 6

3.Colon Cancer | NSABP CO6 - Click for Trial Schema

A clinical trial comparing 5-Fluoroucil (5-FU) plus leucovorin (LV) and UFT plus LV for the treatment of patients with stages II and III carcinoma of the colon.

Adjuvant chemotherapy with 5-FU and LV given after surgery improves recurrence and cure rates for people with early colon cancer. Most chemotherapy is given through a tube into the vein (intra-venous infusion). UFT is a new chemotherapy drug that is given as a tablet; its effects on the cancer are similar to 5-FU. This study will determine if using UFT instead of 5-FU will result in people living as long and with better quality of life.

Principal Investigators
Professor Michael Findlay Medical Oncologist Auckland Hospital, NZ

Supported by
National Surgical Adjuvant Breast and Bowel Project Inc. (USA)

4.Stage 11 & 111 Colon Cancer | NSABP CO7 - Click for Trial Schema

A clinical trial comparing 5-Fluorouracil (5-FU) plus leucovorin (LV) and oxaliplatin with 5-FU plus LV for the treatment of patients with stages II and III carcinoma of the colon.

Adjuvant chemotherapy with 5-FU and LV given after surgery improves recurrence and cure rates for people with early colon cancer. Oxaliplatin is a chemotherapy drug that can help people with advanced colon cancer. This study will determine if adding oxaliplatin to standard treatment can also help people with early colon cancer.

Principal Investigators
Professor Michael Findlay Medical Oncologist Auckland Hospital, NZ

Supported by
National Surgical Adjuvant Breast and Bowel Project Inc. (USA), Sanofi-Aventis Inc. (USA) and Sanofi-Aventis Australia P/L

5.Advanced GIST | AG0102 GIST / EORTC 62005 - Click for Trial Schema

Phase III randomised, multi-centre, international trial to determine the relation between dose and clinical activity of STI—571 in patients with unresectable or metastatic malignant gastrointestinal stromal tumors expressing the c—kit receptor tyrosine kinase (CD117).

Gastro—intestinal stromal tumours (GIST) are rare and highly resistant to standard chemotherapy and radiation. A new chemotherapy tablet called STI—571 (Glivec®) has produced dramatic responses in people with this kind of cancer. This trial is comparing higher and lower doses of STI—571 to see which works best. Trials of STI—571 in other cancers are being planned around the world.

Principal Investigators
Professor John Zalcberg Medical Oncologist Peter MacCallum Cancer Centre, VIC

Supported by
Novartis Pharmaceuticals Australia P/L, Novartis International AG (Switzerland) and European Organisation for Research and Treatment of Cancer (Belgium)

6.Liver Metastases (Colorectal) | EORTC 40983 - Click for Trial Schema

Pre- and post-operative chemotherapy with oxaliplatin 5-FU/LV versus surgery alone in resectable liver metastases from colorectal origin - phase III study.

Cancers from the colon or rectum often spread to the liver (metastases). Sometimes these cancers can be removed from the liver with an operation, but the cancer often comes back later (recurs). This trial will determine if adding chemotherapy for three months before and after surgery can improve the cure and recurrence rates.

Principal Investigators
Doctor Euan Walpole Medical Oncologist Princess Alexandra Hospital, QLD

Supported by
European Organisation for Research and Treatment of Cancer (Belgium)

12.European Study of Adjuvant Chemotherapies in Resectable Pancreatic Cancer (ESPAC) 3 - Click for Trial Schema

Phase III adjuvant trial in pancreatic cancer comparing: 5-fluorouracil + D-L folinic acid with gemcitabine or no adjuvant treatment.

Surgery is the best treatment for cancers of the pancreas that have not spread further. However, despite the best surgery, the cancer often comes back (recurs). This trial will determine if chemotherapy given after surgery can prevent or delay cancer recurrence and its effects on quality of life.

Principal Investigators
Doctor Rob Padbury Hepatobiliary Surgeon Flinders Medical Centre, SA
Conjoint Professor David Goldstein Medical Oncologist Prince of Wales Hospital, NSW

Supported by
National Health and Medical Research Council (Australia) via the University of Sydney
Cancer Council New South Wales
Cancer Council Queensland
Cancer Council South Australia
Cancer Council Victoria

13.Adjuvant GIST | EORTC 62024 - Click for Trial Schema

Intermediate and high-risk localised, completely resected, gastro-intestinal stromal tumours (GIST) expressing c-kit receptor: A controlled randomised trial on adjuvant imatinib mesylate (Glivec®) versus no further therapy after completing surgery.

Imatinib mesylate is highly effective in advanced, unresectable GIST. However, the long-term effect of this agent on survival outcomes remains unclear. This study will compare the effect of adjuvant imatinib mesylate versus observation only on the prognosis of patients with completely resected localised gastrointestinal stromal tumours at intermediate- or high-risk of relapse.

Principal Investigators
Doctor Dusan Kotasek Medical Oncologist Ashford Cancer Centre, SA

Supported by
Novartis Pharmaceuticals Australia P/L

14. Metastatic Colorectal Cancer | CO.20 - Click for Trial Schema

Phase III Randomized Study of BMS-582664 in Combination with Cetuximab (Erbitux®) Versus Placebo in Combination with Cetuximab (Erbitux®) in Patients Previously Treated with Combination Chemotherapy for Metastatic Colorectal Carcinoma.

The CO.20 study is designed to compare the overall survival of patients with previously treated metastatic colorectal carcinoma treated with Brivanib in combination with Cetuximab compared with placebo in combination with Cetuximab. The key question is: Does the addition of an antiangiogenesis inhibitor to standard treatment with an EGFR inhibitor improve the survival of patients with advanced colorectal cancer resistant to all prior chemotherapy regimens?

Principal Investigators
Dr Jeremy Shapiro Medical Oncologist Cabrini Hospital, VIC

Supported by
Bristol-Myers Squibb Company (USA) National Cancer Institute of Canada Clinical Trials Group

15.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

16 .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