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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000681257

Acronym

SURGIST

Enrollment

350

Registered

2009-08-10

Start date

2010-01-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study evaluates the effectiveness of surgery in treating residual disease in patients with metastatic gastrointestinal stromal cell tumours who are responding to treatment with imatinib mesylate. Patients will be randomly divided into two groups. One group will receive surgery to remove residual disease and continue imatinib therapy. The other group will receive continued imatinib therapy only. Participants will be monitored twice in first 6 months, then every 3 months for the first 5 years, and then every 6 months until any progression of disease. Who is it for? -Patients with metastatic GIST. -Patients who have taken 6-12 months of imatinib mesylate. -Patients with either stable disease or tumour regression since the start of imatinib mesylate.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results