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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12609000681257
• Date of registration: 10/08/2009
• Prospective Registration: Yes
• Primary sponsor: European Organisation for Research and Treatment of Cancer (EORTC)
• Public title: A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to imatinib mesylate
• Scientific title: A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to imatinib mesylate
• Date of first enrolment: 10/01/2010
• Target sample size: 350
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12609000681257.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, France, Italy, New Zealand

Contacts

• Name: Karen Bracken

• Name: Karen Bracken

Key inclusion & exclusion criteria

Inclusion criteria: - Histologically confirmed gastro-intestinal stromal tumour (GIST).
- Metastatic disease (liver and/or abdominal cavity)
- Treatment with imatinib mesylate for 6 - 12 months either as standard care or within other clinical studies.
- Progression not experienced on imatinib.
- Surgically resectable disease.
Exclusion criteria: - Previous treatment with imatinib or other tyrosince kinase inhibitor (TKI) other than treatment with imatinib in the past 6 - 12 months.
- Extra-abdominal matastases
- Myocardial infarction, unstable or uncontrolled cardiac disease within 6 months prior to study entry
- Coumarin-type anticoagulant >2mg/day within 7 days prior to study entry
- Pregnancy/breastfeeding

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Other cancer types

Gastro-intestinal stromal tumour (GIST);
Gastro-intestinal stromal tumour (GIST)

Intervention(s)

Surgery to remove residual disease and continued treatment with imatinib mesylate.
Patients allocated to the intervention arm will have surgery within 4 weeks of randomisation. The preferred surgery will be a midline laparotomy, but all abdominal incisions will be allowed.
All patients will be taking imatinib according to standard clinical practice for the duration of the trial.

Primary Outcome(s)

Progression free survival, defined according to the RECIST criteria for tumour response.[For patients randomised to receive surgery:
One month after surgery, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression.
For patient randomised to the control arm (no surgery):
Two months after randomisation, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression.]

Secondary Outcome(s)

Quality of life[For patients randomised to receive surgery:
Before randomization, one month after surgery, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression.
For patient randomised to the control arm (no surgery):
Before randomization, two months after randomisation, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression.]

Pathological response to imatinib (patients in surgery arm only), based on the histology of resected specimens.[Once only at the time of surgery]

Overall survival[For patients randomised to receive surgery:
One month after surgery, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression. After progression survival will be assessed every 6 months until death.
For patient randomised to the control arm (no surgery):
Two months after randomisation, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression. After progression survival will be assessed every 6 months until death.]

Source(s) of Monetary Support

European Organisation for Research and Treatment of Cancer (EORTC)

Secondary Sponsor(s)

Australasian Gastro-Intestinal Trials Group (AGITG)

Ethics review

Status: Approved
Approval date:
Contact:

Sydney South West Area Health Service (SSWAHS) Ethics Review Committee (Royal Prince Alfred Hospital (RPAH) Zone)