Botulinum Toxin for Stomach Cancer Treatment

• ClinicalTrials.gov Identifier: NCT01822210
• Recruitment Status: Completed
• First Posted: April 2, 2013
• Last Update Posted: March 9, 2018
• Sponsor: St. Olavs Hospital
• Collaborator: Norwegian University of Science and Technology
• Information provided by (Responsible Party): St. Olavs Hospital

Tracking Information

• First Submitted Date: March 21, 2013
• First Posted Date: April 2, 2013
• Last Update Posted Date: March 9, 2018
• Actual Study Start Date: January 2013
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Botulinum Toxin for Stomach Cancer Treatment
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stomach Neoplasms

Intervention

Drug: Botox

injection by gastroscopy (100 Allergen units)

Other Name: Botulinum toxin

Study Arms

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 11, 2016): 7
• Original Estimated Enrollment (submitted: March 27, 2013): 10
• Actual Study Completion Date: May 2016
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Eligibility 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 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

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT01822210
• Other Study ID Numbers: StOlav2205; 2012-002493-31 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: St. Olavs Hospital
• Study Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology

Investigators

• Principal Investigator: Jon Erik Grønbech, MD. PhD.; St. Olavs Hospital

• PRS Account: St. Olavs Hospital
• Verification Date: March 2018