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Botulinum Toxin (BOTOX) for Stomach Cancer Treatment

Phase 2
18 Years
80 Years
Open (Enrolling)
Stomach Neoplasms

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Trial Information

Botulinum Toxin (BOTOX) for Stomach Cancer Treatment

Inclusion Criteria

Inclusion criteria:

Patients with verified gastric adenocarcinoma but found non-resectable or inoperable
after evaluation in the appropriate multidisciplinary team at St.Olav Hospital. Trondheim
University Hospital. The inclusion criteria for such patients are:

1. Patients who have received 1.line and 2. line chemotherapy but no longer respond to
such therapy.

2. Patients who, due to toxicity of chemotherapy, cannot be offered such treatment.

3. Patients who, after meticulous information about chemotherapy, still do not want such

4. Patients with performance status (ECOG) 0-2.

Exclusion criteria:

1. Known allergy to any of the components in Botox®

2. Known peripheral motor neuropathy disease ( for example: Amyotrophic Lateral
Sclerosis, ALS), or subclinical or clinical deficiency of neuromuscular
transmission (for example: Myasthenia Gravis or Eaton-Lambert`s Syndrome).

3. Pregnant or lactating women.

4. Another cancer disease that is not under control.

5. Another concomitant treatment for cancer.

6. Serious mental illness.

7. Performance status (ECOG) 3-4.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change of tumor volume in the stomach.

Outcome Description:

Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).

Outcome Time Frame:

Baseline and 8 weeks

Safety Issue:


Principal Investigator

Jon Erik Grønbech, MD. PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St Olavs Hospital Trondheim University Hospital


Norway: Norwegian Medicines Agency

Study ID:




Start Date:

January 2013

Completion Date:

February 2016

Related Keywords:

  • Stomach Neoplasms
  • Botulinum Toxins
  • Injections
  • Stomach
  • Tomography, X-Ray Computed
  • Neoplasms
  • Stomach Neoplasms