NCT01822210

Brief Summary

Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

March 21, 2013

Last Update Submit

March 8, 2018

Conditions

Stomach Neoplasms

Keywords

Botulinum ToxinsInjectionsStomachTomography, X-Ray Computed

Outcome Measures

Primary Outcomes (2)

  • Change of tumor volume in the stomach.

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

    Baseline and 8 weeks

  • Change of tumor volume in the stomach.

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

    8 weeks and 20 weeks

Secondary Outcomes (5)

  • Toxicity

    2 weeks

  • Toxicity

    8 weeks

  • performance status

    2 weeks

  • performance status

    8 weeks

  • performance status

    20 weeks

Study Arms (1)

Botox

EXPERIMENTAL

Injection of Botox in the tumor and surrounding stomach wall.

Drug: Botox

Interventions

BotoxDRUG

injection by gastroscopy (100 Allergen units)

Also known as: Botulinum toxin
Botox

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have received 1.line and 2. line chemotherapy but no longer respond to such therapy.
  • Patients who, due to toxicity of chemotherapy, cannot be offered such treatment.
  • Patients who, after meticulous information about chemotherapy, still do not want such treatment.
  • Patients with performance status (ECOG) 0-2.

You may not qualify if:

  • Known allergy to any of the components in Botox®
  • 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).
  • Pregnant or lactating women.
  • Another cancer disease that is not under control.
  • Another concomitant treatment for cancer.
  • Serious mental illness.
  • Performance status (ECOG) 3-4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital

Trondheim, Norway

Location

Related Publications (1)

  • Andersen G, Zhao CM, Cai X, Rabben HL, Fox JG, Wang TC, Chen D, Gronbech JE. Tu1418 Intragastric Injection of Botulinum Toxin a to Treat Gastric Cancer: An Open-Label Phase II Clinical Trial. Gastroenterology 150: S1251-1252, 2016 https://doi.org/10.1016/S0016-5085(16)34227-5

    RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Botulinum Toxins, Type ABotulinum Toxins

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Jon Erik Grønbech, MD. PhD.

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

April 2, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations

NO(1)