Colo-rectal Cancer2016-003295-46NCT03263663
Optimization of Individualized Therapy for CRCs With Secondary RESISTance Towards Anti-EGFR Targeted Therapy Using an Avatar Model
An observational study of Colo-rectal Cancer and RAS Wild-type, run by PD Dr. med. Volker Heinemann at 1 site in Germany.
Trial summary
In this exploratory phase II trial, the possibility of a personalized treatment after resistance to cetuximab will be evaluated. Therefore, tumor material of all patients shall be obtained, transferred into avatars and treated the same way as in the patient until resistance arises. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, RAS Wild-type, UICC III
- What is being tested?
- targeted substance according to the avatar model
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2017to 1 Jan 2025
- 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: locally advanced colorectal cancer
Who may be able to join
- Male and female patients age ≥ 18 years
- Written declaration of consent
- ECOG Performance Status 0-1
- Life expectancy> 3 months
- Histologically confirmed adenocarcinoma of the colon or rectum at stage UICC III or UICC IV
- Histologically confirmed adenocarcinoma of the colon or rectum in stage UICC II with one of the following risk factors: CEA> 200; T4 tumor, emergency surgery, <12 distant lymph nodes, surgery due to intestinal obstruction (ileus)
- Patient agrees to the preservation of tumor material for the purpose of molecular analyzes including the determination of the genetic profile of the tumor (participation in the project "RESIST")
Who cannot join
- Preoperative Radiotherapy
- Preoperative chemotherapy
- Heart failure> Grade II (functional NYHA classification)
- Existing concomitant disease or condition that would make the patient unsuitable for a study participation or interfere with the safety of the subject
- Any psychological, familial, sociological or geographical event which does not allow observance of the study protocol
- Additional carcinoma therapy (chemotherapy, radiation, biological therapy, immunotherapy or hormonal therapy) during the study
- Known malignant second neoplasia within the last 5 years (except for a basal cell carcinoma or a carcinoma in situ of the uterine cervix).
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Munich - Klinikum der Universitaet Muenchen
Munich, Bavaria, 81379
Sebastian Stintzing, Prof. Dr., +49 89 4400 0, sebastian.stintzing@med.uni-muenchen.de
About this study
Official title: Optimization of Individualized Therapy for CRCs With Secondary RESISTance Towards Anti-EGFR Targeted Therapy Using an Avatar Model (Colon-Resist-Net)
In this exploratory phase II trial, the possibility of a personalized treatment after resistance to cetuximab will be evaluated. Therefore, tumor material of all patients shall be obtained, transferred into avatars and treated the same way as in the patient until resistance arises. These resistant tumor cells are subsequently treated by different targeted treatment combinations in the mouse avatar model to find the most active drug or combination of drugs. This drug or combination of drugs may then be offered to the patient after cetuximab resistance has occurred. Multiple liquid biopsies shall be obtained in patients during first-line treatment with cetuximab as well as during second line experimental treatment to monitor mutations that may be associated with cetuximab resistance. Furthermore at the time of resistance a biopsy should be taken and analyzed to ensure that the mechanism of resistance seen in the avatar model matches with the mechanism of resistance in the individual patient.
- Being tested
- targeted substance according to the avatar model
- Keywords
- colorectal cancer, adjuvant
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
targeted substance according to the avatar modelDrug
individualized second line treatment
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy plus targeted treatment | Patients are treated in second-line with chemotherapy plus a targeted treatment according to the resistance mechanism to cetuximab pretreatment Receives: Drug: targeted substance according to the avatar model | |
| Chemotherapy according to physician choice standard | Patients are treated in second-line with chemotherapy according to physicians choice after cetuximab pretreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free-survival
according to RECIST 1.1
Measured: 5-7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start1 Jan 2017
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PD Dr. med. Volker Heinemann
- Sponsor type
- University, hospital or other
- Collaborators
- Ruhr University of Bochum
- Responsible party
- Sponsor-investigator, PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich
- Investigators
- Sebastian Stintzing, Prof. Dr., Principal investigator, Senior Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263663
- Sponsor's protocol ID
- RESIST
- Acronym
- 2016-003295-46
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2017
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Individualized Therapy for CRCs With Secondary RESISTance Towards Anti-EGFR Targeted Therapy Using an Avatar Model (Colon-Resist-Net)
- ClinicalTrials.gov ID
- NCT03263663
- Acronym / sponsor ID
- 2016-003295-46 / RESIST
- Keywords
- colorectal cancer, adjuvant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- PD Dr. med. Volker HeinemannUniversity, hospital or other
- Collaborators
- Ruhr University of Bochum
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 28 Aug 2017 (actual)
- 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.
In this exploratory phase II trial, the possibility of a personalized treatment after resistance to cetuximab will be evaluated. Therefore, tumor material of all patients shall be obtained, transferred into avatars and treated the same way as in the patient until resistance arises. These resistant tumor cells are subsequently treated by different targeted treatment combinations in the mouse avatar model to find the most active drug or combination of drugs. This drug or combination of drugs may then be offered to the patient after cetuximab resistance has occurred. Multiple liquid biopsies shall be obtained in patients during first-line treatment with cetuximab as well as during second line experimental treatment to monitor mutations that may be associated with cetuximab resistance. Furthermore at the time of resistance a biopsy should be taken and analyzed to ensure that the mechanism of resistance seen in the avatar model matches with the mechanism of resistance in the individual patient.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy plus targeted treatment | – | Drug: targeted substance according to the avatar modelPatients are treated in second-line with chemotherapy plus a targeted treatment according to the resistance mechanism to cetuximab pretreatment |
| Chemotherapy according to physician choice standard | – | –Patients are treated in second-line with chemotherapy according to physicians choice after cetuximab pretreatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- locally advanced colorectal cancer
Key inclusion criteria (7 listed)
- Male and female patients age ≥ 18 years
- Written declaration of consent
- ECOG Performance Status 0-1
- Life expectancy> 3 months
- Histologically confirmed adenocarcinoma of the colon or rectum at stage UICC III or UICC IV
Key exclusion criteria (7 listed)
- Preoperative Radiotherapy
- Preoperative chemotherapy
- Heart failure> Grade II (functional NYHA classification)
- Existing concomitant disease or condition that would make the patient unsuitable for a study participation or interfere with the safety of the subject
- Any psychological, familial, sociological or geographical event which does not allow observance of the study protocol
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 |
|---|---|---|
| targeted substance according to the avatar modelindividualized second line treatment | Drug | Chemotherapy plus targeted treatment |
Primary outcome
Progression-free-survival
Time frame: 5-7 months
according to RECIST 1.1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Individual participant dataSharing planned: Yes
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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.
Sebastian Stintzing, Prof. Dr. principal investigator
Senior Physician
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 Colo-rectal Cancer and RAS Wild-type, run by PD Dr. med. Volker Heinemann 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 7 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: status not confirmed, as of the sponsor's last update on 28 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Stintzing, Prof. Dr. (+49 89 4400 0, sebastian.stintzing@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free-survival (time frame: 5-7 months). 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 28 Aug 2017.