Stomach NeoplasmsPhase 2NCT01822210

Botulinum Toxin for Stomach Cancer Treatment

A Phase 2 study testing Botox in people with Stomach Neoplasms, run by St. Olavs Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stomach Neoplasms
What is being tested?: Botox
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteNorway
Study dates: Jan 2013to May 2016
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Norway1 site

Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital
Trondheim

Other trials in Norway

About this study

Official title: Botulinum Toxin (BOTOX) for Stomach Cancer Treatment

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.

Conditions: Stomach Neoplasms
Being tested: Botox
Keywords: Botulinum Toxins, Injections, Stomach, Tomography, X-Ray Computed
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BotoxDrug
Also called Botulinum toxin
injection by gastroscopy (100 Allergen units)

Study groups in NCT01822210
Study group	Role	What they receive
Botox	Experimental	Injection of Botox in the tumor and surrounding stomach wall. Receives: Drug: Botox

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of tumor volume in the stomach.
Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
Measured: 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).
Measured: 8 weeks and 20 weeks

Secondary outcomes (5)

Toxicity
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: 2 weeks
Toxicity
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: 8 weeks
performance status
ECOG scale
Measured: 2 weeks
performance status
ECOG scale
Measured: 8 weeks
performance status
ECOG scale
Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013May 2016

First posted2 Apr 2013 (estimated)
Study startJan 2013
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
More trials run by St. Olavs HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01822210
Sponsor's protocol ID: StOlav2205
Other IDs: 2012-002493-31
Status last verified: Mar 2018
First submitted: 21 Mar 2013
Last updated: 9 Mar 2018
Results posted: No
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
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B-ALL, DLBCL

All Stomach Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Botulinum Toxin (BOTOX) for Stomach Cancer Treatment
ClinicalTrials.gov ID: NCT01822210
Acronym / sponsor ID: StOlav2205
Conditions: Stomach Neoplasms
Keywords: Botulinum Toxins, Injections, Stomach, Tomography, X-Ray Computed
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: St. Olavs HospitalUniversity, hospital or other
Collaborators: Norwegian University of Science and Technology
Study start: Jan 2013 (actual)
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 2 Apr 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Botox	Experimental	Drug: BotoxInjection of Botox in the tumor and surrounding stomach wall.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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:
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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BotoxAlso: Botulinum toxininjection by gastroscopy (100 Allergen units)	Drug	Botox

Primary outcome

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).

5 secondary outcomes

Toxicity
Time frame: 2 weeks
Toxicity
Time frame: 8 weeks
performance status
Time frame: 2 weeks
performance status
Time frame: 8 weeks
performance status
Time frame: 20 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
Results publicationAndersen 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

Related trials for Stomach Neoplasms

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jon Erik Grønbech, MD. PhD. principal investigator

St. Olavs Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Botox in people with Stomach Neoplasms, run by St. Olavs Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of tumor volume in the stomach. (time frame: Baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01822210, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.