Rectal CancerNCT05607186
Outcomes of Neoadjuvant Therapy for Rectal Cancer in a Tertiary Asian Institute
An observational study of Rectal Cancer and Oncology, run by Singapore General Hospital.
Trial summary
This is a retrospective cohort study that aims to evaluate the correlation of magnetic resonance tumour regression grade (mrTRG) and pathological TRG (pTRG) of locally advanced rectal cancer after neoadjuvant long course chemoradiotherapy as well as the prognostic value of mrTRG on survival. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer, Oncology
- What is being tested?
- neoadjuvant long course chemoradiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with locally advanced rectal cancer were recruited from the Department of Colorectal Surgery, Singapore General Hospital
Who may be able to join
- Rectal cancer
- At least 1 high risk feature on MRI
- Undergo long course neoadjuvant chemoradiotherapy (LCCRT)
Who cannot join
- metastatic disease
- Patients who undergo short course radiotherapy
- Patients without a repeat MRI after completion of LCCRT
About this study
Official title: Outcomes of Neoadjuvant Therapy for Rectal Cancer in a Tertiary Asian
This is a retrospective cohort study that aims to evaluate the correlation of magnetic resonance tumour regression grade (mrTRG) and pathological TRG (pTRG) of locally advanced rectal cancer after neoadjuvant long course chemoradiotherapy as well as the prognostic value of mrTRG on survival.
- Conditions
- Rectal Cancer, Oncology
- Being tested
- neoadjuvant long course chemoradiotherapy
- Medical subject headings
- Rectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant long course chemoradiotherapyRadiation
neoadjuvant long course chemoradiotherapy consist of radiosensitizing 5FU or capecitabine and 50.4 Gy in 28 fractions over 5 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between mrTRG and pTRG
Measured: Between 1 Jan 2011 to 31 Dec 2016
Secondary outcomes (1)
Prognostic value of mrTRG on survival outcomes of rectal cancer patients
Measured: Between 1 Jan 2011 to 31 Dec 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Jan 2011
- Primary completion31 Dec 2016
- Study completion31 Dec 2019
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 Singapore General 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607186
- Sponsor's protocol ID
- 2019/2342
- Status last verified
- Oct 2022
- First submitted
- 31 Oct 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Neoadjuvant Therapy for Rectal Cancer in a Tertiary Asian
- ClinicalTrials.gov ID
- NCT05607186
- Acronym / sponsor ID
- 2019/2342
- Conditions
- Rectal Cancer, Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Nov 2022 (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.
This is a retrospective cohort study that aims to evaluate the correlation of magnetic resonance tumour regression grade (mrTRG) and pathological TRG (pTRG) of locally advanced rectal cancer after neoadjuvant long course chemoradiotherapy as well as the prognostic value of mrTRG on survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with locally advanced rectal cancer were recruited from the Department of Colorectal Surgery, Singapore General Hospital
Key inclusion criteria (3 listed)
- Rectal cancer
- At least 1 high risk feature on MRI
- Undergo long course neoadjuvant chemoradiotherapy (LCCRT)
Key exclusion criteria (3 listed)
- metastatic disease
- Patients who undergo short course radiotherapy
- Patients without a repeat MRI after completion of LCCRT
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 |
|---|---|---|
| neoadjuvant long course chemoradiotherapyneoadjuvant long course chemoradiotherapy consist of radiosensitizing 5FU or capecitabine and 50.4 Gy in 28 fractions over 5 weeks | Radiation | – |
Primary outcome
Correlation between mrTRG and pTRG
Time frame: Between 1 Jan 2011 to 31 Dec 2016
1 secondary outcome
Prognostic value of mrTRG on survival outcomes of rectal cancer patients
Time frame: Between 1 Jan 2011 to 31 Dec 2016
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 7 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Oncology, run by Singapore General Hospital.
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 3 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 7 Nov 2022. 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?
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?
Correlation between mrTRG and pTRG (time frame: Between 1 Jan 2011 to 31 Dec 2016). 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 7 Nov 2022.