Locally Advanced Rectal CancerPhase 2NCT00931203
Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer
A Phase 2 study testing Celecoxib in people with Locally Advanced Rectal Cancer, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
This is a single arm phase II trial with combined celecoxib, tegafur-uracil, folinate and preoperative radiotherapy for patients with locally advanced rectal cancer. The primary end point is pathological complete response (pCR) rate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Celecoxib
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2008to Apr 2013
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with resectable or potentially resectable adenocarcinoma of the rectum.
- Clinical stage by Magnetic Resonance Image (MRI) of pelvis, ultrasonography of liver and Chest X ray: AJCC T2 N1-2M0 or T3-4 N0-2M0 (patients who require diverting loop colostomy are eligible). Nuclear medicine study (whole body bone scan or PET scan) can be performed if clinically indicated.
- Bi-dimensionally measurable disease by MRI, which can be done with pelvic array coil and intrarectal tube.
- Age greater than 18 years and < 80 years, ECOG performance status < 2
- Biopsy proven adenocarcinoma, superior margin of the tumor below the L5-S1 spine junction.
- WBC > 3.5 x109/L, neutrophil count > 1.5x109/L, platelet count > 100x109/L, serum bilirubin < 1.25xULN (upper limit of normal), AST/ALT < 3x ULN, serum creatinine < 1.25xULN.
- Informed consent signed.
Who cannot join
- Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy.
- History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix).
- Pregnancy.
- Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU.
- Cardiovascular disease like congestive heart failure, symptomatic coronary artery disease, or myocardiac infarction.
- History of peptic ulcer disease or NSAID-related gastrointestinal bleeding
- Use of aspirin, other NSAID or celecoxib in the two weeks prior to study entry.
- Patients taking warfarin or other anticoagulating medicine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer
This is a single arm phase II trial with combined celecoxib, tegafur-uracil, folinate and preoperative radiotherapy for patients with locally advanced rectal cancer. The primary end point is pathological complete response (pCR) rate. The secondary endpoints are toxicities of combined celecoxib and chemoradiation, negative resection margin rate, clinical tumor response by magnetic resonance imaging (MRI), sphincter preservation rate, disease-free survival and overall survival.
Read the detailed description
The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer.
The secondary objectives of this study are to determine:
- Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer.
- Negative resection margins (circumferential resection margin) rate.
- Downstaging rate.
- Sphincter preservation rate
- Locoregional and distant failure rate.
- Overall survival
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Celecoxib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Celecoxib (400 mg/d) will be continued from day 1 to 65
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer.
Measured: 10 weeks
Secondary outcomes (4)
1.Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer.
Measured: > 28 weeks
Negative resection margins (circumferential resection margin) rate.
Measured: > 28 weeks
Downstaging rate.
Measured: > 28 weeks
Sphincter preservation rate.
Measured: > 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJul 2008
- Primary completionJun 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Changhua Christian Hospital, Chi Mei Medical Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, Mackay Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Lin Wei Wang, MD, Principal investigator, National Health Research of Institutes, Taiwan Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931203
- Sponsor's protocol ID
- T2207
- Status last verified
- Jul 2009
- First submitted
- 1 Jul 2009
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT00931203
- Acronym / sponsor ID
- T2207
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Changhua Christian Hospital, Chi Mei Medical Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, Mackay Memorial Hospital
- Study start
- Jul 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 2 Jul 2009 (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.
This is a single arm phase II trial with combined celecoxib, tegafur-uracil, folinate and preoperative radiotherapy for patients with locally advanced rectal cancer. The primary end point is pathological complete response (pCR) rate. The secondary endpoints are toxicities of combined celecoxib and chemoradiation, negative resection margin rate, clinical tumor response by magnetic resonance imaging (MRI), sphincter preservation rate, disease-free survival and overall survival.
Detailed description
The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer.
The secondary objectives of this study are to determine:
- Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer.
- Negative resection margins (circumferential resection margin) rate.
- Downstaging rate.
- Sphincter preservation rate
- Locoregional and distant failure rate.
- Overall survival
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with resectable or potentially resectable adenocarcinoma of the rectum.
- Clinical stage by Magnetic Resonance Image (MRI) of pelvis, ultrasonography of liver and Chest X ray: AJCC T2 N1-2M0 or T3-4 N0-2M0 (patients who require diverting loop colostomy are eligible). Nuclear medicine study (whole body bone scan or PET scan) can be performed if clinically indicated.
- Bi-dimensionally measurable disease by MRI, which can be done with pelvic array coil and intrarectal tube.
- Age greater than 18 years and < 80 years, ECOG performance status < 2
- Biopsy proven adenocarcinoma, superior margin of the tumor below the L5-S1 spine junction.
Key exclusion criteria (8 listed)
- Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy.
- History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix).
- Pregnancy.
- Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU.
- Cardiovascular disease like congestive heart failure, symptomatic coronary artery disease, or myocardiac infarction.
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 |
|---|---|---|
| CelecoxibCelecoxib (400 mg/d) will be continued from day 1 to 65 | Drug | – |
Primary outcome
The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer.
Time frame: 10 weeks
4 secondary outcomes
1.Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer.
Time frame: > 28 weeks
Negative resection margins (circumferential resection margin) rate.
Time frame: > 28 weeks
Downstaging rate.
Time frame: > 28 weeks
Sphincter preservation rate.
Time frame: > 28 weeks
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 4 May 2016.
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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.
Lin Wei Wang, MD principal investigator
National Health Research of Institutes, Taiwan Cooperative Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib in people with Locally Advanced Rectal Cancer, run by National Health Research Institutes, Taiwan 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 7 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: finished, as of the sponsor's last update on 4 May 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer. (time frame: 10 weeks). 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 4 May 2016.