Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Botulinum Toxin for Stomach Cancer Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01822210
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Tracking Information
First Submitted Date  ICMJE March 21, 2013
First Posted Date  ICMJE April 2, 2013
Last Update Posted Date March 9, 2018
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
  • Change of tumor volume in the stomach. [ Time Frame: Baseline and 8 weeks ]
    Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
  • Change of tumor volume in the stomach. [ Time Frame: 8 weeks and 20 weeks ]
    Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
  • Toxicity [ Time Frame: 2 weeks ]
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
  • Toxicity [ Time Frame: 8 weeks ]
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
  • performance status [ Time Frame: 2 weeks ]
    ECOG scale
  • performance status [ Time Frame: 8 weeks ]
    ECOG scale
  • performance status [ Time Frame: 20 weeks ]
    ECOG scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxin for Stomach Cancer Treatment
Official Title  ICMJE Botulinum Toxin (BOTOX) for Stomach Cancer Treatment
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stomach Neoplasms
Intervention  ICMJE Drug: Botox
injection by gastroscopy (100 Allergen units)
Other Name: Botulinum toxin
Study Arms  ICMJE Experimental: Botox
Injection of Botox in the tumor and surrounding stomach wall.
Intervention: Drug: Botox
Publications * 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2016)
7
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2013)
10
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 treatment.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01822210
Other Study ID Numbers  ICMJE StOlav2205
2012-002493-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Olavs Hospital
Study Sponsor  ICMJE St. Olavs Hospital
Collaborators  ICMJE Norwegian University of Science and Technology
Investigators  ICMJE
Principal Investigator: Jon Erik Grønbech, MD. PhD. St. Olavs Hospital
PRS Account St. Olavs Hospital
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP