Gastric CancerNCT01220934
An Observational Study of Herceptin (Trastuzumab) in Patients With HER2-positive Advanced Gastric Cancer
An observational study of Gastric Cancer, run by Hoffmann-La Roche at 1 site in Germany.
Trial summary
This observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be collected for approximately 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 443 participants
- Where
- 1 siteGermany
- Study dates
- 16 Apr 2010to 1 Jun 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastric cancer patients receiving Herceptin in routine clinical practice
Who may be able to join
- Adult patients, >/=18 years of age
- Histologically confirmed advanced adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) with locally advanced and/or metastatic disease
- HER2-positive tumor
- Patients who are eligible for treatment with Herceptin according to the judgment of the physician
Who cannot join
- Unwilling or unable to sign informed consent form
- Any contraindications, interactions and incompatibilities to Herceptin
Trial locations and contacts
1 site in 1 country.
Germany1 site
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
Frankfurt, 60488
About this study
Official title: Clinical Practice Surveillance of the Use of Herceptin in Patients With HER2-positive Advanced Adenocarcinoma of the Stomach or Gastro-esophageal Junction (GEJ) (HERMES)
This observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be collected for approximately 12 months.
- Conditions
- Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 12 months
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 12 months
Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 12 months
Secondary outcomes (7)
Documentation of the testing process for HER2-positive tumors
Measured: 12 months
Assessment of implementation of guidelines and recommendations of Herceptin administration in routine clinical practice
Measured: 12 months
Documentation of backbone chemotherapy treatment and concomitant medication
Measured: 12 months
Quality of Life questionnaire
Measured: 12 months
Surveillance of pain intensity and analgesic consumption
Measured: 12 months
Surveillance of weight change
Measured: 12 months
Safety (incidence of adverse events)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study start16 Apr 2010
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220934
- Sponsor's protocol ID
- ML22834
- Status last verified
- Jun 2018
- First submitted
- 28 Sep 2010
- Last updated
- 20 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Practice Surveillance of the Use of Herceptin in Patients With HER2-positive Advanced Adenocarcinoma of the Stomach or Gastro-esophageal Junction (GEJ) (HERMES)
- ClinicalTrials.gov ID
- NCT01220934
- Acronym / sponsor ID
- ML22834
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2010 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 14 Oct 2010 (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.
This observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be collected for approximately 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastric cancer patients receiving Herceptin in routine clinical practice
Key inclusion criteria (4 listed)
- Adult patients, >/=18 years of age
- Histologically confirmed advanced adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) with locally advanced and/or metastatic disease
- HER2-positive tumor
- Patients who are eligible for treatment with Herceptin according to the judgment of the physician
Key exclusion criteria (2 listed)
- Unwilling or unable to sign informed consent form
- Any contraindications, interactions and incompatibilities to Herceptin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 12 months
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 12 months
Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 12 months
7 secondary outcomes
Documentation of the testing process for HER2-positive tumors
Time frame: 12 months
Assessment of implementation of guidelines and recommendations of Herceptin administration in routine clinical practice
Time frame: 12 months
Documentation of backbone chemotherapy treatment and concomitant medication
Time frame: 12 months
Quality of Life questionnaire
Time frame: 12 months
Surveillance of pain intensity and analgesic consumption
Time frame: 12 months
Surveillance of weight change
Time frame: 12 months
Safety (incidence of adverse events)
Time frame: 12 months
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 20 Jun 2018.
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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.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Hoffmann-La Roche at 1 site in Germany.
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 4 inclusion and 2 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 20 Jun 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 Germany. 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.
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?
Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2018.