Rectal CancerNCT02979795
Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis
An observational study of Rectal Cancer and Chemoradiation, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent chemoradiotherapy (CCRT) before surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rectal Cancer, Chemoradiation
- What is being tested?
- Preoperative chemoradiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2016to Dec 2020
- How long will I take part?
- 5 Years
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rectal cancer patients in China Medical University Hospital (Age: 20 yrs and older)
Who may be able to join
- Rectal cancer patients in China Medical University Hospital (Age limit: 20 yrs and older)
Who cannot join
- Pregnancy, Disabilities
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Huang Chih-Yang, Ph.D, 886422052121 ext. 3677, T96752@mail.cmuh.org.tw
About this study
Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that localized radiation not only destroys local tumor but also inhibits the growth of tumor at the remote site, has been observed. This effect is believed to be associated with tumor immune response. In addition, other immune checkpoint molecules, such as Programmed cell death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after CCRT, more than 50% of patients were still either having persistent disease or developed distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this project, thus, aims at exploring the evolution of factors that may affect the abscopal effect and immune checkpoint functions in tissues and in blood before and after CCRT.
Read the detailed description
For most patients, preoperative chemoradiotherapy results in clinically tumor regression, but the degree of response varies among patients. There are approximately 40-60% of LARC patients treated with CCRT achieve some degree of pathologic response. However, there is yet an effective method before the commencement of CCRT that can predict how patients will respond to CCRT and can subsequently render better survival. Identify patents who will benefit most from CCRT is crucial not only in lowering treatment-related morbidity and sustaining local control but also to improve survival rate in LARC.
- Conditions
- Rectal Cancer, Chemoradiation
- Being tested
- Preoperative chemoradiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative chemoradiotherapyProcedure or surgery
Preoperative chemoradiotherapy. 2.5 Gray/fraction (Total in 45-54 Gray)
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor regression rate
complete tumor regression rate(TRG) with tumor regression graded at at surgical resection at 8 weeks after completion of chemoradiotherapy
Measured: within 8 weeks after completion of chemoradiotherapy
Secondary outcomes (4)
Disease free survival
Measured: 5 year
Overall survival
Measured: 5 year
Local recurrence
Measured: 5 year
Distant metastasis
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-San Clifford Chao, China Medical University Hospital
- Investigators
- Kan Sun Clifford Chao, MD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979795
- Sponsor's protocol ID
- CMUH105-REC2-072
- Status last verified
- Nov 2016
- First submitted
- 30 Nov 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis
- ClinicalTrials.gov ID
- NCT02979795
- Acronym / sponsor ID
- CMUH105-REC2-072
- Conditions
- Rectal Cancer, Chemoradiation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Dec 2016 (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.
Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that localized radiation not only destroys local tumor but also inhibits the growth of tumor at the remote site, has been observed. This effect is believed to be associated with tumor immune response. In addition, other immune checkpoint molecules, such as Programmed cell death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after CCRT, more than 50% of patients were still either having persistent disease or developed distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this project, thus, aims at exploring the evolution of factors that may affect the abscopal effect and immune checkpoint functions in tissues and in blood before and after CCRT.
Detailed description
For most patients, preoperative chemoradiotherapy results in clinically tumor regression, but the degree of response varies among patients. There are approximately 40-60% of LARC patients treated with CCRT achieve some degree of pathologic response. However, there is yet an effective method before the commencement of CCRT that can predict how patients will respond to CCRT and can subsequently render better survival. Identify patents who will benefit most from CCRT is crucial not only in lowering treatment-related morbidity and sustaining local control but also to improve survival rate in LARC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rectal cancer patients in China Medical University Hospital (Age: 20 yrs and older)
Key inclusion criteria (1 listed)
- Rectal cancer patients in China Medical University Hospital (Age limit: 20 yrs and older)
Key exclusion criteria (1 listed)
- Pregnancy, Disabilities
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 |
|---|---|---|
| Preoperative chemoradiotherapyPreoperative chemoradiotherapy. 2.5 Gray/fraction (Total in 45-54 Gray) | Procedure or surgery | – |
Primary outcome
Tumor regression rate
Time frame: within 8 weeks after completion of chemoradiotherapy
complete tumor regression rate(TRG) with tumor regression graded at at surgical resection at 8 weeks after completion of chemoradiotherapy
4 secondary outcomes
Disease free survival
Time frame: 5 year
Overall survival
Time frame: 5 year
Local recurrence
Time frame: 5 year
Distant metastasis
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Kan Sun Clifford Chao, MD principal investigator
China Medical University Hospital
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 Rectal Cancer and Chemoradiation, run by China Medical University Hospital at 1 site in Taiwan.
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 2 Dec 2016. 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 Taiwan. 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 Kan Sun Clifford Chao, MD (886422052121 ext. 2976, D94032@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor regression rate (time frame: within 8 weeks after completion of chemoradiotherapy). 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 2 Dec 2016.