Colorectal CancerPhase 1NCT01456923
Chemotherapy With DNA Damaging Agents In Colorectal Cancer
A Phase 1 study testing Treatment with chemotherapy, Only chemotherapy treatment for study cohort and surgery in people with Colorectal Cancer, run by Centro Hospitalar Nordeste.
Trial summary
Chemotherapy Treatment alone with DNA damaging drugs might be as effective as chemotherapy combined with surgery in colorectal cancer (CRC) avoiding surgery complications. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Treatment with chemotherapy, Only chemotherapy treatment for study cohort and surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients that did not underwent surgery
Who cannot join
- patients that underwent surgery
About this study
Official title: Phase 1 Study Of The Efficacy Of Chemotherapy With DNA Damaging Agents Versus Surgery In Colorectal Cancer
Chemotherapy Treatment alone with DNA damaging drugs might be as effective as chemotherapy combined with surgery in colorectal cancer (CRC) avoiding surgery complications.
- Conditions
- Colorectal Cancer
- Being tested
- Treatment with chemotherapy, Only chemotherapy treatment for study cohort, surgery
- Keywords
- DNA damaging agents
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with chemotherapyOther
Only chemotherapy treatment for study cohortOther
Control patients were treated both with surgery and chemotherapy. Study patients were treated only with chemotherapy
surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control (chemotherapy and surgery) | Active comparator | Patients treated with chemotherapy + surgery Receives: Other: Treatment with chemotherapy; Procedure: surgery |
| Study | Active comparator | Patients treated only with chemotherapy Receives: Other: Only chemotherapy treatment for study cohort |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Nordeste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Cadavez Pedro, Centro Hospitalar Nordeste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456923
- Sponsor's protocol ID
- ACCRC10
- Status last verified
- Sep 2008
- First submitted
- 18 Oct 2011
- Last updated
- 21 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study Of The Efficacy Of Chemotherapy With DNA Damaging Agents Versus Surgery In Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01456923
- Acronym / sponsor ID
- ACCRC10
- Conditions
- Colorectal Cancer
- Keywords
- DNA damaging agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Centro Hospitalar NordesteUniversity, hospital or other
- First posted
- 21 Oct 2011 (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.
Chemotherapy Treatment alone with DNA damaging drugs might be as effective as chemotherapy combined with surgery in colorectal cancer (CRC) avoiding surgery complications.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (chemotherapy and surgery) | Active comparator | Other: Treatment with chemotherapy, Procedure: surgeryPatients treated with chemotherapy + surgery |
| Study | Active comparator | Other: Only chemotherapy treatment for study cohortPatients treated only with chemotherapy |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients that did not underwent surgery
Key exclusion criteria (1 listed)
- patients that underwent surgery
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 |
|---|---|---|
| Treatment with chemotherapy | Other | Control (chemotherapy and surgery) |
| Only chemotherapy treatment for study cohortControl patients were treated both with surgery and chemotherapy. Study patients were treated only with chemotherapy | Other | Study |
| surgery | Procedure or surgery | Control (chemotherapy and surgery) |
Primary outcome
Not reported in the source record.
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 21 Oct 2011.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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?
A Phase 1 study testing Treatment with chemotherapy, Only chemotherapy treatment for study cohort and surgery in people with Colorectal Cancer, run by Centro Hospitalar Nordeste.
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 1 inclusion and 1 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 21 Oct 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 21 Oct 2011.