Colorectal CancerNCT04525313
The Prediction Model of Avastin Plus Chemotherapy in Unresectable Ras Mutant CRLM Patients
An observational study of Colorectal Cancer and Liver Metastases, run by Fudan University.
Trial summary
establishment and validation of the prediction model of avastin plus chemotherapy as first line treatment in simultaneous ras mutant unresectable CRLM patients Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Dec 2022
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Simultaneous unresectable CRLM patients(ras mutation) with primary tumor resection before Avastin plus chemotherapy as first line treatment
Who may be able to join
- age 18-75 years, histologically proven colorectal adenocarcinoma, with liver-dominant disease, a life expectancy of > 3 months, ras mutation, unresectable simultaneous liver metastasis, ECOG 0-1, written informed consent for participation in the trial.
Who cannot join
- patients with known hypersensitivity reactions to any of the components of the study treatments, pregnancy or breast-feeding, accepted chemotherapy, radiotherapy and target therapy before primary tumor resection, other previous malignancy within 5 years, known drug abuse/alcohol abuse, ECOG>1, legal incapacity or limited legal capacity.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Prediction Model of Avastin Plus Chemotherapy as First Line Treatment in Unresectable Ras Mutant Colorectal Liver Metastase (CRLM) Patients
establishment and validation of the prediction model of avastin plus chemotherapy as first line treatment in simultaneous ras mutant unresectable CRLM patients
Read the detailed description
Ras mutant unresectable CRLM patients with primary tumor resection followed by avastin in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, 58 CRLM patients were classified into two groups (CR+PR vs SD+PD). Primary samples of the two group patients will be sequenced by mass spectrum. After MS sequencing, a prediction model will be estimated. Another 58 CRLM patients will be inclued for validation of the prediction model.
- Conditions
- Colorectal Cancer, Liver Metastases
- Medical subject headings
- Colorectal 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 |
|---|---|---|
| training set | 58 unresectable simutaneous CRLM patients with ras mutation accepted Avastin plus chemotherapy treatment after primary tumor resection between 2013.01 and 2017.12. | |
| validation set | another 58 unresectable simutaneous CRLM patients with ras mutation accepted Avastin plus chemotherapy treatment after primary tumor resection between 2018.01 and 2022.12. |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
response rate will be assessed by local MDT every two months
Measured: 6 months
Secondary outcomes (2)
overall survival
overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment
Measured: 3 years
progression free survival
progression free survival will be assessed by local MDT every two months during treatment, and telephone follow-up every three month after treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Retrospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525313
- Sponsor's protocol ID
- BECOME1
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction Model of Avastin Plus Chemotherapy as First Line Treatment in Unresectable Ras Mutant Colorectal Liver Metastase (CRLM) Patients
- ClinicalTrials.gov ID
- NCT04525313
- Acronym / sponsor ID
- BECOME1
- Conditions
- Colorectal Cancer, Liver Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Aug 2020 (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.
establishment and validation of the prediction model of avastin plus chemotherapy as first line treatment in simultaneous ras mutant unresectable CRLM patients
Detailed description
Ras mutant unresectable CRLM patients with primary tumor resection followed by avastin in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, 58 CRLM patients were classified into two groups (CR+PR vs SD+PD). Primary samples of the two group patients will be sequenced by mass spectrum. After MS sequencing, a prediction model will be estimated. Another 58 CRLM patients will be inclued for validation of the prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training set | – | –58 unresectable simutaneous CRLM patients with ras mutation accepted Avastin plus chemotherapy treatment after primary tumor resection between 2013.01 and 2017.12. |
| validation set | – | –another 58 unresectable simutaneous CRLM patients with ras mutation accepted Avastin plus chemotherapy treatment after primary tumor resection between 2018.01 and 2022.12. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Simultaneous unresectable CRLM patients(ras mutation) with primary tumor resection before Avastin plus chemotherapy as first line treatment
Key inclusion criteria (1 listed)
- age 18-75 years, histologically proven colorectal adenocarcinoma, with liver-dominant disease, a life expectancy of > 3 months, ras mutation, unresectable simultaneous liver metastasis, ECOG 0-1, written informed consent for participation in the trial.
Key exclusion criteria (1 listed)
- patients with known hypersensitivity reactions to any of the components of the study treatments, pregnancy or breast-feeding, accepted chemotherapy, radiotherapy and target therapy before primary tumor resection, other previous malignancy within 5 years, known drug abuse/alcohol abuse, ECOG>1, legal incapacity or limited legal capacity.
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
Time frame: 6 months
response rate will be assessed by local MDT every two months
2 secondary outcomes
overall survival
Time frame: 3 years
progression free survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Liver Metastases, run by Fudan University.
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 1 inclusion and 1 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jianmin Xu (+8613501984869 ext. +8613501984869, xujmin@aiiyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 6 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 25 Aug 2020.