Locally Advanced Rectal CancerNCT03149978
Tumor Response Prediction in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer Using Metabonomics Analysis
An observational study of Locally Advanced Rectal Cancer, run by Zhu Ji at 1 site in China.
Trial summary
This study suggested an effective application of pattern recognition, which figured the possible biological function of potential bio-markers of rectal cancer found in our study based on their chemical structures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2014to 30 Jun 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage T3 or T4 and/or N+ rectal adenocarcinoma cancer eligible for neoadjuvant chemoradiation
Who may be able to join
- history of primary rectal cancer with distance from anal verge being less than 12 cm;
- histologically confirmed adenocarcinoma;
- initial pathological stage of T3 or T4 and/or N+;
- no history of initial distant metastases;
- Karnofsky Performance Status score of ≥75
- ≥18 years;≤75 years
- sign the inform consent
Who cannot join
- pregnancy or breast-feeding women
- serious medical illness
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Ji Zhu, MD
About this study
This study suggested an effective application of pattern recognition, which figured the possible biological function of potential bio-markers of rectal cancer found in our study based on their chemical structures. Hence, this study identified the precursor protein and metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation of locally advanced rectal cancer
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- Neoadjuvant Chemoradiation, treatment effect prediction, metabonomics
What is being measured
The primary outcome is the main question the study is designed to answer.
TRG
Tumor regression grade
Measured: Surgery scheduled 6-8 weeks after the end of chemoradiation
Secondary outcomes (5)
Pathologic Complete Response
Measured: Surgery scheduled 6-8 weeks after the end of chemoradiation
Local Control rate
Number of participants with pelvic failure after surgery, evaluated using Kaplan-Meier Curve
Measured: From date of randomization until the date of first documented pelvic failure, assessed up to 10 years
Disease-free Survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years
Overall Survival
Measured: From date of randomization until the date of death from any cause, assessed up to 10 years
Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0
Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Jul 2014
- Primary completion30 Dec 2017 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Rectal CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhu Ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Ji, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149978
- Sponsor's protocol ID
- FDRT-006
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jia H, Shen X, Guan Y, Xu M, Tu J, Mo M, Xie L, Yuan J, Zhang Z, Cai S, Zhu J, Zhu Z. Predicting the pathological response to neoadjuvant chemoradiation using untargeted metabolomics in locally advanced rectal cancer. Radiother Oncol. 2018 Sep;128(3):548-556. doi: 10.1016/j.radonc.2018.06.022. Epub 2018 Jul 2.
PubMed 30041962
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Response Prediction in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer Using Metabonomics Analysis
- ClinicalTrials.gov ID
- NCT03149978
- Acronym / sponsor ID
- FDRT-006
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- Neoadjuvant Chemoradiation, treatment effect prediction, metabonomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhu JiUniversity, hospital or other
- Study start
- 1 Jul 2014
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 11 May 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.
This study suggested an effective application of pattern recognition, which figured the possible biological function of potential bio-markers of rectal cancer found in our study based on their chemical structures. Hence, this study identified the precursor protein and metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation of locally advanced rectal cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage T3 or T4 and/or N+ rectal adenocarcinoma cancer eligible for neoadjuvant chemoradiation
Key inclusion criteria (7 listed)
- history of primary rectal cancer with distance from anal verge being less than 12 cm;
- histologically confirmed adenocarcinoma;
- initial pathological stage of T3 or T4 and/or N+;
- no history of initial distant metastases;
- Karnofsky Performance Status score of ≥75
Key exclusion criteria (3 listed)
- pregnancy or breast-feeding women
- serious medical illness
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
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
TRG
Time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
Tumor regression grade
5 secondary outcomes
Pathologic Complete Response
Time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
Local Control rate
Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 10 years
Disease-free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years
Overall Survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years
Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Derived from this study: PubMed 30041962Jia H, Shen X, Guan Y, Xu M, Tu J, Mo M, Xie L, Yuan J, Zhang Z, Cai S, Zhu J, Zhu Z. Predicting the pathological response to neoadjuvant chemoradiation using untargeted metabolomics in locally advanced rectal cancer. Radiother Oncol. 2018 Sep;128(3):548-556. doi: 10.1016/j.radonc.2018.06.022. Epub 2018 Jul 2.
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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.
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 Locally Advanced Rectal Cancer, run by Zhu Ji at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 12 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 China. 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 Ji Zhu, MD (+86-2164175590, leo.zhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRG (time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03149978, which also lists 1 linked publication.
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 12 May 2017.