Colorectal CancerNCT01163305
PET-CT and Circulating Tumor Cells in Colorectal Cancer
An observational study of Colorectal Cancer and Metastasis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to identify an early indicator of drug efficacy in patients with advanced colorectal cancer - a prospective evaluation of circulating tumor cells, positron-emission tomography scan and RECIST criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastasis
- What is being tested?
- Chemotherapy
- How many people
- 84 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Jun 2010to 27 Apr 2017
- 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: patients with metastatic colorectal cancer
Who may be able to join
- Metastatic colorectal cancer patients not received prior drug treatment for metastatic CRC
- Age >= 18 years
- (ECOG) performance status of 0-2
- Measurable tumor sites by RECIST criteria
- Adequate bone marrow, renal \& hepatic functions
Who cannot join
- Patients with diabetes mellitus
- presence of hyperglycemia
- Pregnant or lactating patients
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: Identifying an Early Indicator of Drug Efficacy in Patients With Advanced Colorectal Cancer - a Prospective Evaluation of Circulating Tumor Cells, Positron-emission Tomography Scan and RECIST Criteria
The purpose of this study is to identify an early indicator of drug efficacy in patients with advanced colorectal cancer - a prospective evaluation of circulating tumor cells, positron-emission tomography scan and RECIST criteria.
Read the detailed description
- To determine if measuring both tumor metabolic response (via FDG-PET scan) \& circulating tumor cells (CirTC) at 4 weeks after starting treatment, is a better predictor of clinical outcome than measuring either modality alone in patients with metastatic colorectal cancer (CRC) who are undergoing first-line oxaliplatin-based chemotherapy.
- To determine if a new method of assessing drug response (measuring tumor metabolic response via FDG-PET \& CirTC at 4 weeks after starting treatment) better predicts clinical outcome than the conventional method (measuring radiological changes in tumor dimensions at 10 weeks after starting treatment via the 'Response Evaluation Criteria in Solid Tumors' - RECIST).
- Conditions
- Colorectal Cancer, Metastasis
- Being tested
- Chemotherapy
- Keywords
- Identifying an early indicator of drug efficacy
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| metastatic colorectal cancer | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy
Measured: 2 years
Secondary outcomes (5)
Overall survival
Measured: 4 years
Progression-free survival
Measured: 4 years
serum carcinoembryonic antigen (CEA) level
Measured: 4 years
Circulating tumor cells level changes at 4 weeks after chemotherapy
Measured: 2 years
RECIST-based tumor response at 10 weeks after chemotherapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study start30 Jun 2010
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
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 Chinese University of Hong KongThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Brigette Ma, MD, FRCP, Principal investigator, Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163305
- Sponsor's protocol ID
- COL016
- Status last verified
- Apr 2017
- First submitted
- 24 Jun 2010
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying an Early Indicator of Drug Efficacy in Patients With Advanced Colorectal Cancer - a Prospective Evaluation of Circulating Tumor Cells, Positron-emission Tomography Scan and RECIST Criteria
- ClinicalTrials.gov ID
- NCT01163305
- Acronym / sponsor ID
- COL016
- Conditions
- Colorectal Cancer, Metastasis
- Keywords
- Identifying an early indicator of drug efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Jun 2010 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 15 Jul 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.
The purpose of this study is to identify an early indicator of drug efficacy in patients with advanced colorectal cancer - a prospective evaluation of circulating tumor cells, positron-emission tomography scan and RECIST criteria.
Detailed description
- To determine if measuring both tumor metabolic response (via FDG-PET scan) \& circulating tumor cells (CirTC) at 4 weeks after starting treatment, is a better predictor of clinical outcome than measuring either modality alone in patients with metastatic colorectal cancer (CRC) who are undergoing first-line oxaliplatin-based chemotherapy.
- To determine if a new method of assessing drug response (measuring tumor metabolic response via FDG-PET \& CirTC at 4 weeks after starting treatment) better predicts clinical outcome than the conventional method (measuring radiological changes in tumor dimensions at 10 weeks after starting treatment via the 'Response Evaluation Criteria in Solid Tumors' - RECIST).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metastatic colorectal cancer | – | Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with metastatic colorectal cancer
Key inclusion criteria (5 listed)
- Metastatic colorectal cancer patients not received prior drug treatment for metastatic CRC
- Age >= 18 years
- (ECOG) performance status of 0-2
- Measurable tumor sites by RECIST criteria
- Adequate bone marrow, renal \& hepatic functions
Key exclusion criteria (3 listed)
- Patients with diabetes mellitus
- presence of hyperglycemia
- Pregnant or lactating patients
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 |
|---|---|---|
| ChemotherapyThe majority of patients offered either oxaliplatin or irinotecan-based chemotherapy | Drug | metastatic colorectal cancer |
Primary outcome
Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy
Time frame: 2 years
5 secondary outcomes
Overall survival
Time frame: 4 years
Progression-free survival
Time frame: 4 years
serum carcinoembryonic antigen (CEA) level
Time frame: 4 years
Circulating tumor cells level changes at 4 weeks after chemotherapy
Time frame: 2 years
RECIST-based tumor response at 10 weeks after chemotherapy
Time frame: 2 years
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 8 May 2017.
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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.
Brigette Ma, MD, FRCP principal investigator
Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
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 Colorectal Cancer and Metastasis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 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 8 May 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 Hong Kong. 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?
Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy (time frame: 2 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 8 May 2017.