Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002493-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox | Experimental | Injection of Botox in the tumor and surrounding stomach wall. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox | Drug | injection by gastroscopy (100 Allergen units) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | 2 weeks |
| Toxicity | Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 |
Not provided
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:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jon Erik Grønbech, MD. PhD. | St. Olavs Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 8 weeks |
| performance status | ECOG scale | 2 weeks |
| performance status | ECOG scale | 8 weeks |
| performance status | ECOG scale | 20 weeks |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |