Rectal CancerPhase 2NCT00176787
Radiation Therapy With Capecitabine in Rectal Cancer
A Phase 2 study testing Capecitabine, Radiation and Surgery in people with Rectal Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This study will use an experimental combination of treatment with the drug Capecitabine and radiation therapy prior to an operation for removal of the patient's tumor. The drug Capecitabine is an oral form of a drug called 5-FU which has been widely used to treat rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Capecitabine, Radiation and Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Jun 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients may not have received previous pelvic irradiation for any indication, or previous chemotherapy for cancer therapy within the preceding 6 months.
- Patients must have no other serious medical or psychiatric illness that would limit the ability of the patient to receive protocol therapy or provide informed consent.
- Pregnant or lactating women may not participate. Women/men of reproductive potential must agree to use an effective contraceptive method.
- Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046)
This study will use an experimental combination of treatment with the drug Capecitabine and radiation therapy prior to an operation for removal of the patient's tumor. The drug Capecitabine is an oral form of a drug called 5-FU which has been widely used to treat rectal cancer.
This is a phase II clinical trial, which means that the physician will be studying the reactions of the patient's body and tumor to treatment with Capecitabine and radiation therapy. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. The study also will see what kind of side effects this experimental treatment causes and see how often these side effects occur.
Preliminary human studies using Capecitabine and radiation therapy have produced encouraging results with acceptable side effects.
- Conditions
- Rectal Cancer
- Being tested
- Capecitabine, Radiation, Surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
RadiationProcedure or surgery
SurgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectives:
In patients with locally advanced rectal cancer treated with preoperative radiation and capecitabine chemotherapy to estimate:
a. the pathologic complete response rate
b. the clinical response rate
c. the proportion of patients converted to sphincter sparing surgery
clinical response rate
Measured: 2 cycles
d. The quantitative and qualitative toxicities of the treatment approach
e. The relationship of intratumoral levels of thymidylate synthase, dipyrimidine dehydrogenase and thymidine phosphorylase determined immunohistochemically to response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2000
- Primary completionMay 2005
- Study completionJun 2007
Why it stopped: recruitment goals met
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 University of Michigan Rogel Cancer CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Mark Zalupski, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176787
- Sponsor's protocol ID
- UMCC 0046
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 10 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046)
- ClinicalTrials.gov ID
- NCT00176787
- Acronym / sponsor ID
- UMCC 0046
- Conditions
- Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment goals met
- Enrolment
- 30 participants
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Oct 2000
- Primary completion
- May 2005 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 15 Sep 2005 (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 study will use an experimental combination of treatment with the drug Capecitabine and radiation therapy prior to an operation for removal of the patient's tumor. The drug Capecitabine is an oral form of a drug called 5-FU which has been widely used to treat rectal cancer.
This is a phase II clinical trial, which means that the physician will be studying the reactions of the patient's body and tumor to treatment with Capecitabine and radiation therapy. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. The study also will see what kind of side effects this experimental treatment causes and see how often these side effects occur.
Preliminary human studies using Capecitabine and radiation therapy have produced encouraging results with acceptable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients may not have received previous pelvic irradiation for any indication, or previous chemotherapy for cancer therapy within the preceding 6 months.
- Patients must have no other serious medical or psychiatric illness that would limit the ability of the patient to receive protocol therapy or provide informed consent.
- Pregnant or lactating women may not participate. Women/men of reproductive potential must agree to use an effective contraceptive method.
- Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome are not eligible.
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 |
|---|---|---|
| Capecitabine | Drug | – |
| Radiation | Procedure or surgery | – |
| Surgery | Procedure or surgery | – |
Primary outcome
Objectives:
In patients with locally advanced rectal cancer treated with preoperative radiation and capecitabine chemotherapy to estimate:
a. the pathologic complete response rate
b. the clinical response rate
c. the proportion of patients converted to sphincter sparing surgery
clinical response rate
Time frame: 2 cycles
d. The quantitative and qualitative toxicities of the treatment approach
e. The relationship of intratumoral levels of thymidylate synthase, dipyrimidine dehydrogenase and thymidine phosphorylase determined immunohistochemically to response
Results and safety
The study was stopped early (reason given: recruitment goals met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2008.
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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.
Mark Zalupski, M.D. principal investigator
University of Michigan Rogel Cancer Center
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 Capecitabine, Radiation and Surgery in people with Rectal Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
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 0 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Jan 2008. 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 United States. 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 was stopped early (reason given: recruitment goals met). Results are not available in the source record.
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?
Objectives:. The study lists 8 primary outcomes in all. 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 10 Jan 2008.