Trial · NCT00399035
Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
NCT00399035, Phase 3, Completed, AstraZeneca; results first posted 2012-10-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer. Trials, record NCT00399035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00399035
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
- NCT number
- NCT00399035
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,254 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Cediranib, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), XELOX (Capecitabine and Oxaliplatin), Cediranib Placebo
- First posted
- 2006-11-14
- Last updated
- 2016-12-28
- Other registries' IDs
- eudract:2006-001194-14
- Results first posted
- 2012-10-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest. | RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression \[non-PD\]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions. |
| Primary | Overall Survival | Baseline through to date of death upto and including data cut off date of 21/03/10 | Number of months from randomisation to the date of death from any cause |
| Secondary | Overall Response Rate | Baseline through to date of death upto and including data cut off date of 21/03/10 | Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi |
| Secondary | Best Percentage Change in Tumour Size | Baseline through to date of death upto and including data cut off date of 21/03/10 | Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions |
| Secondary | Duration of Response | Treatment period from initial response up until data cut-off date of 21/03/10 | Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies. |
| Secondary | Rate of Resection of Liver Metastases | Post-randomisation until end of study | Number of patients undergoing liver resection, based on patients with liver disease at baseline |
| Secondary | Time to Wound Healing Complications | Post-randomisation until end of study | Number of days from post-randomisation surgery until wound healing complications |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest. | Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation.The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group. | Months | MEDIAN |
| PRIMARY | Overall Survival | Baseline through to date of death upto and including data cut off date of 21/03/10 | Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group. | Months | MEDIAN |
| SECONDARY | Overall Response Rate | Baseline through to date of death upto and including data cut off date of 21/03/10 | Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group. | Participants | NUMBER |
| SECONDARY | Best Percentage Change in Tumour Size | Baseline through to date of death upto and including data cut off date of 21/03/10 | Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group. | Percentage [change in tumour size (mm) ] | MEAN |
| SECONDARY | Duration of Response | Treatment period from initial response up until data cut-off date of 21/03/10 | Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group. | Months | MEDIAN |
| SECONDARY | Rate of Resection of Liver Metastases | Post-randomisation until end of study | Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group. | Participants | NUMBER |
| SECONDARY | Time to Wound Healing Complications | Post-randomisation until end of study | Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Cediranib 20 mg | 8.6 | Inter-Quartile Range 5.5 to 12.1 | Months | |
| Progression-free Survival | Placebo | 8.2 | Inter-Quartile Range 4.1 to 11.1 | Months | |
| Overall Survival | Cediranib 20 mg | 19.7 | Inter-Quartile Range 11.0 to 36.1 | Months | |
| Overall Survival | Placebo | 18.9 | Inter-Quartile Range 11.0 to 28.9 | Months | |
| Overall Response Rate | Cediranib 20 mg | 254 | Participants | ||
| Overall Response Rate | Placebo | 178 | Participants | ||
| Best Percentage Change in Tumour Size | Cediranib 20 mg | -42.49 | Standard Deviation 28.139 | Percentage [change in tumour size (mm) ] | |
| Best Percentage Change in Tumour Size | Placebo | -40.61 | Standard Deviation 31.992 | Percentage [change in tumour size (mm) ] | |
| Duration of Response | Cediranib 20 mg | 8.5 | Inter-Quartile Range 5.9 to 12.7 | Months | |
| Duration of Response | Placebo | 6.9 | Inter-Quartile Range 4.8 to 11.0 | Months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cediranib 20 mg/Day | 502 | |
| Overall Study | STARTED | Cediranib 30 mg/Day | 216 | |
| Overall Study | STARTED | Placebo | 358 | |
| Overall Study | COMPLETED | Cediranib 20 mg/Day | 189 | |
| Overall Study | COMPLETED | Cediranib 30 mg/Day | 58 | |
| Overall Study | COMPLETED | Placebo | 106 | |
| Overall Study | NOT COMPLETED | Cediranib 20 mg/Day | 313 | |
| Overall Study | NOT COMPLETED | Cediranib 30 mg/Day | 158 | |
| Overall Study | NOT COMPLETED | Placebo | 252 |
Source ClinicalTrials.gov
Adverse events885
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 |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cediranib 30mg | 56 | 214 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cediranib 20mg | 139 | 500 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 84 | 358 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cediranib 30mg | 49 | 214 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cediranib 20mg | 138 | 500 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 75 | 358 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cediranib 30mg | 15 | 214 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cediranib 20mg | 84 | 500 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 39 | 358 | |
| other | Anaemia | Blood and lymphatic system disorders | Cediranib 30mg | 24 | 214 |
1 to 10 of 885Source ClinicalTrials.gov
See all 885 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cediranib 30mg | ||
| Total, all-cause mortality | Cediranib 20mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Cediranib 30mg | 209 | 214 |
| Total, other adverse events | Cediranib 20mg | 485 | 500 |
| Total, other adverse events | Placebo | 341 | 358 |
| Total, serious adverse events | Cediranib 30mg | 94 | 214 |
| Total, serious adverse events | Cediranib 20mg | 204 | 500 |
| Total, serious adverse events | Placebo | 105 | 358 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23510802 | DERIVED |
Source PubMed
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 |
|---|---|
| Cediranib 20 mg vs Placebo: Overall Response Rate | Trial comparisons |
| Cediranib 20 mg vs Placebo: Rate of Resection of Liver Metastases | 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/NCT00399035
GET https://conductscience.org/api/trials/v1/NCT00399035/events?page=2