Metastatic Colorectal CarcinomaNCT03096899
A Study to Estimate Overall Survival in Patients Receiving Best Supportive Care for Treatment-Resistant, Metastatic Colorectal Carcinoma
An observational study of Metastatic Colorectal Carcinoma, run by The Rogosin Institute at 1 site in United States.
Trial summary
The primary objective of this study is to estimate overall survival in patients only receiving best supportive care (BSC) for treatment-resistant, metastatic colorectal carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Carcinoma
- What is being tested?
- Observational
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 22 Aug 2018
- 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: The study patient population is composed of patients with treatment-resistant, metastatic colorectal cancer who are only receiving BSC.
Who may be able to join
- Patients must meet all of the following criteria to be considered eligible to participate in the study:
- Adult men or women, aged 18 years or older, with histologically-confirmed, metastatic adenocarcinoma of the colon or rectum that is resistant to available treatment options, including at least two such options from available chemotherapy, targeted and other regimens.
- Radiographically documented evidence of disease progression from the most recent therapy administered prior to the initiation of BSC.
- Life expectancy of at least six weeks, in the Investigator's opinion, at the time of disease progression from the most recent therapy administered prior to the initiation of BSC.
- In the Investigator's opinion, a surgical candidate at the time of disease progression. Initiation of treatment with BSC only within two months.
- Able to provide written informed consent (by patient or family member or health proxy).
Who cannot join
- Patients who, at the time of disease progression from the most recent therapy administered prior to the initiation of BSC, meet any of the following criteria will be excluded from participating in the study:
- Documentation of hepatic blood flow abnormalities, i.e., portal vein hypertension and thrombosis, and/or a large volume of ascites.
- Documentation of concurrent cancer of any other type (Note: patients with non-melanoma skin cancers are still considered eligible).
- Documentation of positive test result for human immunodeficiency virus (HIV) or any hepatitis (other than Hepatitis A).
- Considered by the Investigator to be unsuitable for participation in the study upon review of medical history, physical examination or clinical laboratory test results.-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study to Estimate Overall Survival in Patients Receiving Best Supportive Care for Treatment-Resistant, Metastatic Colorectal Carcinoma
The primary objective of this study is to estimate overall survival in patients only receiving best supportive care (BSC) for treatment-resistant, metastatic colorectal carcinoma. The primary efficacy outcome is overall survival, defined as the time from the date of the radiographic scan demonstrating disease progression post available treatments (time of origin, T0) to death from any cause.
Read the detailed description
This is a retrospective chart review and prospective observational study. Patients will be considered for enrollment if they are receiving BSC and have already decided independently of this study not to pursue further therapeutic treatment of their cancer. Patients must have received at least two prior treatments for their disease, such as chemotherapy, targeted therapy or other regimens.
The study will consist of administration of informed consent, which will include permission to review medical records and record relevant medical information, agreement to be followed for survival, and evaluation of the appropriate inclusion/exclusion entry criteria.
Patients will not have any study-specific assessments performed as part of this study, and will be followed only for survival.
Approximately 80 patients with treatment-resistant, metastatic colorectal cancer who are only receiving BSC, will be entered in the study at no more than five sites in the United States
- Conditions
- Metastatic Colorectal Carcinoma
- Being tested
- Observational
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Best Supportive Care
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Death from any cause.
Measured: From the date of prior radiographically documented disease progression associated with the most recent therapy administered prior to the initiation of BSC to the date of death, assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study startJan 2016
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Why it stopped: The investigator conducting the study determined that the entry criteria for the proposed subjects was too difficult to determine in a retrospective review.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CarcinomaStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rogosin Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barry Smith, M.D., Ph.D., Study director, The Rogosin Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096899
- Sponsor's protocol ID
- RI-CR-002
- Status last verified
- Aug 2018
- First submitted
- 16 Mar 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Estimate Overall Survival in Patients Receiving Best Supportive Care for Treatment-Resistant, Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT03096899
- Acronym / sponsor ID
- RI-CR-002
- Conditions
- Metastatic Colorectal Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The investigator conducting the study determined that the entry criteria for the proposed subjects was too difficult to determine in a retrospective review.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Rogosin InstituteUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 30 Mar 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.
The primary objective of this study is to estimate overall survival in patients only receiving best supportive care (BSC) for treatment-resistant, metastatic colorectal carcinoma. The primary efficacy outcome is overall survival, defined as the time from the date of the radiographic scan demonstrating disease progression post available treatments (time of origin, T0) to death from any cause.
Detailed description
This is a retrospective chart review and prospective observational study. Patients will be considered for enrollment if they are receiving BSC and have already decided independently of this study not to pursue further therapeutic treatment of their cancer. Patients must have received at least two prior treatments for their disease, such as chemotherapy, targeted therapy or other regimens.
The study will consist of administration of informed consent, which will include permission to review medical records and record relevant medical information, agreement to be followed for survival, and evaluation of the appropriate inclusion/exclusion entry criteria.
Patients will not have any study-specific assessments performed as part of this study, and will be followed only for survival.
Approximately 80 patients with treatment-resistant, metastatic colorectal cancer who are only receiving BSC, will be entered in the study at no more than five sites in the United States
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study patient population is composed of patients with treatment-resistant, metastatic colorectal cancer who are only receiving BSC.
Key inclusion criteria (6 listed)
- Patients must meet all of the following criteria to be considered eligible to participate in the study:
- Adult men or women, aged 18 years or older, with histologically-confirmed, metastatic adenocarcinoma of the colon or rectum that is resistant to available treatment options, including at least two such options from available chemotherapy, targeted and other regimens.
- Radiographically documented evidence of disease progression from the most recent therapy administered prior to the initiation of BSC.
- Life expectancy of at least six weeks, in the Investigator's opinion, at the time of disease progression from the most recent therapy administered prior to the initiation of BSC.
- In the Investigator's opinion, a surgical candidate at the time of disease progression. Initiation of treatment with BSC only within two months.
Key exclusion criteria (5 listed)
- Patients who, at the time of disease progression from the most recent therapy administered prior to the initiation of BSC, meet any of the following criteria will be excluded from participating in the study:
- Documentation of hepatic blood flow abnormalities, i.e., portal vein hypertension and thrombosis, and/or a large volume of ascites.
- Documentation of concurrent cancer of any other type (Note: patients with non-melanoma skin cancers are still considered eligible).
- Documentation of positive test result for human immunodeficiency virus (HIV) or any hepatitis (other than Hepatitis A).
- Considered by the Investigator to be unsuitable for participation in the study upon review of medical history, physical examination or clinical laboratory test results.-
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 |
|---|---|---|
| ObservationalBest Supportive Care | Other | – |
Primary outcome
Overall Survival
Time frame: From the date of prior radiographically documented disease progression associated with the most recent therapy administered prior to the initiation of BSC to the date of death, assessed up to 10 years
Death from any cause.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Barry Smith, M.D., Ph.D. study director
The Rogosin Institute
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 Metastatic Colorectal Carcinoma, run by The Rogosin Institute at 1 site in United States.
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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 31 Aug 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Overall Survival (time frame: From the date of prior radiographically documented disease progression associated with the most recent therapy administered prior to the initiation of BSC to the date of death, assessed up to 10 years). 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 31 Aug 2018.