Rectal CancerNCT01671891
Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer
An observational study of Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
Rectal cancer is one of the most common malignant tumors in the world. However, there's also no reliable and sensitive method to monitor diseases and evaluate therapy responses till now. Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a promising method in this field. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- radiation therapy and capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Feb 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: rectal cancer diagnosed with stage II-IV
Who may be able to join
- Histologically verified rectal carcinoma
- Locally advanced tumor (cT3-4 and/or N+ by transrectal ultrasound and/or pelvic magnetic resonance imaging)
- the distance from anal verge <= 12cm
- with or without metastasis
- Age 18-75 years old
- ECOG PS 0-2
- No previous chemotherapy or radiotherapy for rectal carcinoma
- Written informed consent
Who cannot join
- no histologically verified rectal carcinoma
- rectal cancer with stage I
- distance from verge >12cm
- age <=18 or >=75 years old
- performed previously chemotherapy or radiotherapy
- infection diseases within three months
- serious other diseases
- no written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Wenjie Sun, Master, 86-21-64175590, ganjumedecin@hotmail.com
Zhen Zhang, PhD,MD
About this study
Rectal cancer is one of the most common malignant tumors in the world. However, there's also no reliable and sensitive method to monitor diseases and evaluate therapy responses till now. Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a promising method in this field. This study is to investigate the role of circulating tumor cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- radiation therapy, capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)
- Keywords
- rectal cancer, circulating tumor cells, predict responses
- Medical subject headings
- Rectal Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
45-55Gy
capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)Drug
Also called Xeloda
radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)
| Study group | Role | What they receive |
|---|---|---|
| rectal cancer with stage II-IV | rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin Receives: Radiation: radiation therapy; Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw) |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulating tumor cells level changes after radiotherapy
Measured: 3 years
Secondary outcomes (5)
overall survival
Measured: 3 years
disease-free survival
Measured: 3 years
serum carcinoembryonic antigen (CEA) level
Measured: 3 years
pathological response (tumor regression grade)if surgery
Measured: 3 years
RECIST-based tumor response at 10 week after radiotherapy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startFeb 2012
- Study completionFeb 2013 (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 Fudan UniversityThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671891
- Sponsor's protocol ID
- SCRC-NM-1001
- Status last verified
- Aug 2012
- First submitted
- 19 Jul 2012
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer
- ClinicalTrials.gov ID
- NCT01671891
- Acronym / sponsor ID
- SCRC-NM-1001
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, circulating tumor cells, predict responses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Study completion
- Feb 2013 (estimated)
- First posted
- 24 Aug 2012 (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 is one of the most common malignant tumors in the world. However, there's also no reliable and sensitive method to monitor diseases and evaluate therapy responses till now. Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a promising method in this field. This study is to investigate the role of circulating tumor cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rectal cancer with stage II-IV | – | Radiation: radiation therapy, Drug: capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)rectal cancer with stage II-IV intervention: pelvic radiotherapy (45-55Gy) concurrent chemotherapy using capecitabine and oxaliplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- rectal cancer diagnosed with stage II-IV
Key inclusion criteria (8 listed)
- Histologically verified rectal carcinoma
- Locally advanced tumor (cT3-4 and/or N+ by transrectal ultrasound and/or pelvic magnetic resonance imaging)
- the distance from anal verge <= 12cm
- with or without metastasis
- Age 18-75 years old
Key exclusion criteria (8 listed)
- no histologically verified rectal carcinoma
- rectal cancer with stage I
- distance from verge >12cm
- age <=18 or >=75 years old
- performed previously chemotherapy or radiotherapy
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 |
|---|---|---|
| radiation therapy45-55Gy | Radiation | rectal cancer with stage II-IV |
| capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)Also: Xelodaradiotherapy concurrent chemotherapy(capecitabine+oxaliplatin) | Drug | rectal cancer with stage II-IV |
Primary outcome
circulating tumor cells level changes after radiotherapy
Time frame: 3 years
5 secondary outcomes
overall survival
Time frame: 3 years
disease-free survival
Time frame: 3 years
serum carcinoembryonic antigen (CEA) level
Time frame: 3 years
pathological response (tumor regression grade)if surgery
Time frame: 3 years
RECIST-based tumor response at 10 week after radiotherapy
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
- circulating tumor cells in colorectal cancerLink provided by the sponsor.
- Circulating tumors cells as biomarkers: progress toward biomarker qualificationLink provided by the sponsor.
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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 Rectal Cancer, run by Fudan University 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 8 inclusion and 8 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 24 Aug 2012. 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 Wenjie Sun, Master (86-21-64175590-1600, ganjumedecin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circulating tumor cells level changes after radiotherapy (time frame: 3 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 24 Aug 2012.