Trial · NCT00127036
Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)
NCT00127036, Phase 2, Terminated, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2012-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A). Trials, record NCT00127036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00127036
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)
- NCT number
- NCT00127036
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Adenocarcinoma, Colon Cancer
- Interventions
- XELOX, XELIRI, Bevacizumab
- First posted
- 2005-08-05
- Last updated
- 2017-03-23
- Results first posted
- 2012-04-05
- Limitations and caveats
Study was Terminated early, not Completed. Study Drug now on the market. Due to slow accrual, too few patients who had both clinical and microarray data to perform the proposed analysis. 65 of 92 patients consented were assigned to treatment arms.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Per Treatment Arm, Per Tumor Tissue Response Classifier | 30 Days After End of Treatment - Average of 6 Months | Investigators would develop tumor tissue classifiers to predict response to the XELOX arm or XELIRI arm; with gene expression profiles on 75 patients on each of 2 arms, construct 2 classifiers to distinguish responders (complete responses, partial responses, stable disease) from non-responders (progressive disease). |
| Secondary | Number of Participants Per Treatment Arm, With Overall Survival (OS) | 30 Days After End of Treatment - Average of 6 Months | Investigators planned to evaluate the overall survival of colorectal cancer (CRC) patients treated with XELOX + bevacizumab (Arm A) or XELIRI + bevacizumab (Arm B). |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | 30 Days After End of Treatment - Average of 6 Months | Review of Serious Adverse Events (SAEs) To assess the toxicity associated with Arms A and B. Response rates and toxicity rates for each arm were to be estimated and exact (using Casella's method) 95% confidence intervals for those proportions computed. With the anticipated 75 patients in each arm, these estimated proportions would have standard errors not exceeding 7%. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Per Treatment Arm, Per Tumor Tissue Response Classifier | 30 Days After End of Treatment - Average of 6 Months | Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data. | ||
| SECONDARY | Number of Participants Per Treatment Arm, With Overall Survival (OS) | 30 Days After End of Treatment - Average of 6 Months | Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data. | ||
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | 30 Days After End of Treatment - Average of 6 Months | All participants. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | XELOX + Bevacizumab | 9 | participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | XELIRI + Bevacizumab | 11 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | XELOX + Bevacizumab | 34 | |
| Overall Study | STARTED | XELIRI + Bevacizumab | 31 | |
| Overall Study | COMPLETED | XELOX + Bevacizumab | 26 | |
| Overall Study | COMPLETED | XELIRI + Bevacizumab | 20 | |
| Overall Study | NOT COMPLETED | XELOX + Bevacizumab | 8 | |
| Overall Study | NOT COMPLETED | XELIRI + Bevacizumab | 11 |
Source ClinicalTrials.gov
Adverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Abdominal distention | Gastrointestinal disorders | XELOX + Bevacizumab | 0 | 34 | 0 |
| serious | Abdominal distention | Gastrointestinal disorders | XELIRI + Bevacizumab | 1 | 31 | 1 |
| serious | Abdominal pain | Gastrointestinal disorders | XELOX + Bevacizumab | 1 | 34 | 1 |
| serious | Abdominal pain | Gastrointestinal disorders | XELIRI + Bevacizumab | 1 | 31 | 1 |
| serious | Anorexia | Gastrointestinal disorders | XELOX + Bevacizumab | 0 | 34 | 0 |
| serious | Anorexia | Gastrointestinal disorders | XELIRI + Bevacizumab | 1 | 31 | 1 |
| serious | Bilirubin - hospitalized | Blood and lymphatic system disorders | XELOX + Bevacizumab | 0 | 34 | 0 |
| serious | Bilirubin - hospitalized | Blood and lymphatic system disorders | XELIRI + Bevacizumab | 1 | 31 | 1 |
| serious | CNS cerebrovascular ischemia | Nervous system disorders | XELOX + Bevacizumab | 0 | 34 | 0 |
| serious | CNS cerebrovascular ischemia | Nervous system disorders | XELIRI + Bevacizumab | 1 | 31 | 1 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | XELOX + Bevacizumab | ||
| Total, all-cause mortality | XELIRI + Bevacizumab | ||
| Total, other adverse events | XELOX + Bevacizumab | 0 | 34 |
| Total, other adverse events | XELIRI + Bevacizumab | 0 | 31 |
| Total, serious adverse events | XELOX + Bevacizumab | 9 | 34 |
| Total, serious adverse events | XELIRI + Bevacizumab | 11 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| XELOX + Bevacizumab vs XELIRI + Bevacizumab: Number of Participants With Serious Adverse Events (SAEs) | Trial comparisons |
| XELOX + Bevacizumab vs XELIRI + Bevacizumab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00127036
GET https://conductscience.org/api/trials/v1/NCT00127036/events?page=2