Trial · NCT02340949
Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer
NCT02340949, Phase 2, Completed, Grupo Espanol Multidisciplinario del Cancer Digestivo; results first posted 2021-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer. Trials, record NCT02340949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02340949
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer
- NCT number
- NCT02340949
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 180 participants, actual
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
- Conditions
- Rectal Cancer
- Interventions
- Aflibercept, 5-Fluoruracil, Oxaliplatin, Leucovorin
- First posted
- 2015-01-19
- Last updated
- 2021-05-03
- Results first posted
- 2021-05-03
- Limitations and caveats
There are no overall limitations and caveats. In detail: There were 6 patients that received treatment doses that did not matched protocol specifications. These were notified as protocol major deviations to the competent authorities and ethics committees. The effect of these deviations on results is not significant.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Achieving Pathologic Complete Response (pCR). | From baseline until 2 years and 2 months | The number of patients achieving pCR after induction therapy with mFOLFOX6 +/- aflibercept followed by chemotherapy (CT)/radiotherapy (RT). pCR will be defined as the absence of viable tumor cells in the primary tumor and in the lymph nodes (T0N0) |
| Secondary | Number of Patients Achieving Pathological Parameters of Efficacy: R0 Resection, Tumor Regression Grade, and Circular Radial Margin Rate | From baseline until 2 years and 2 months | R0 resection is defined as complete tumor removal, and correlates with good prognosis. Tumor regression grade (TRG) is defined as presence of residual tumor after preoperative therapy. This was assessed by magnetic resonance imaging (MRI) according to the 5-point regression grading scale established by Mandard: TRG1 (complete response with no residual cancer), TRG2 (rare residual cancer), TRG3 (fibrosis outgrowing residual cancer), TRG4 (residual cancer outgrowing fibrosis) and TRG5 (absence of regression). Circular Radial Margin (CRM) is defined as the distance from the margin of normal tissue to the edge of tumor tissue in the resected primary tumor the measured by histopathology study after surgery. A margin of ≤1 mm is considered to be a negative prognostic factor for local recurrence. |
| Secondary | Number of Participants With Significant MRI Changes Post Intervention, as Defined by T Downstaging | From baseline until 2 years and 2 months | Tumor size is assessed by MRI to determine the T stage. T Downstaging: defined as a lower pathologic T stage compared to pre-treatment T stage. |
| Secondary | Number of Patients Reporting Adverse Events (AEs) | From baseline until 2 years and 2 months | The safety and tolerability of the study therapy were assessed by means of AEs and changes in laboratory data. AEs were coded and evaluated using the NCI-CTCAE v4.0 toxicity criteria (if NCI-CTCAE are not applicable, MedDRA was used). |
| Secondary | Number of Patients Reporting Surgical Complications | From surgical intervention up to 30 days post-surgery, within a general time frame of 2 years and 2 months per study protocol | Surgical complications will be assessed by means of AEs reported during 30 days post surgery. |
| Secondary | Disease Free Survival (DFS) Rate at 3 Years | At 3 years after study treatment completion, within a general time frame of 5 years and two months | DFS rate is defined as the percentage of participants without local recurrences at 3-years post study treatment. Here we report the DFS rate at 3-years after completing the Study treatment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Achieving Pathologic Complete Response (pCR). | From baseline until 2 years and 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Achieving Pathological Parameters of Efficacy: R0 Resection, Tumor Regression Grade, and Circular Radial Margin Rate | From baseline until 2 years and 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Significant MRI Changes Post Intervention, as Defined by T Downstaging | From baseline until 2 years and 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Reporting Adverse Events (AEs) | From baseline until 2 years and 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Reporting Surgical Complications | From surgical intervention up to 30 days post-surgery, within a general time frame of 2 years and 2 months per study protocol | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease Free Survival (DFS) Rate at 3 Years | At 3 years after study treatment completion, within a general time frame of 5 years and two months | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Achieving Pathologic Complete Response (pCR). | mFOLFOX6 + Aflibercept | Yes | 25 | Participants | |
| Number of Patients Achieving Pathologic Complete Response (pCR). | mFOLFOX6 | Yes | 9 | Participants | |
| Number of Patients Achieving Pathologic Complete Response (pCR). | mFOLFOX6 + Aflibercept | No | 90 | Participants | |
| Number of Patients Achieving Pathologic Complete Response (pCR). | mFOLFOX6 | No | 56 | Participants | |
| Number of Patients Achieving Pathological Parameters of Efficacy: R0 Resection, Tumor Regression Grade, and Circular Radial Margin Rate | mFOLFOX6 + Aflibercept | R0 rate / Yes | 101 | Participants | |
| Number of Patients Achieving Pathological Parameters of Efficacy: R0 Resection, Tumor Regression Grade, and Circular Radial Margin Rate | mFOLFOX6 | R0 rate / Yes | 60 | Participants | |
| Number of Patients Achieving Pathological Parameters of Efficacy: R0 Resection, Tumor Regression Grade, and Circular Radial Margin Rate | mFOLFOX6 + Aflibercept | R0 rate / No | 2 | Participants | |
| Number of Patients Achieving Pathological Parameters of Efficacy: R0 Resection, Tumor Regression Grade, and Circular Radial Margin Rate | mFOLFOX6 | R0 rate / No | 2 | Participants | |
| Number of Patients Achieving Pathological Parameters of Efficacy: R0 Resection, Tumor Regression Grade, and Circular Radial Margin Rate | mFOLFOX6 + Aflibercept | R0 rate / Not available | 12 | Participants | |
| Number of Patients Achieving Pathological Parameters of Efficacy: R0 Resection, Tumor Regression Grade, and Circular Radial Margin Rate | mFOLFOX6 | R0 rate / Not available | 3 | Participants |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | mFOLFOX6 + Aflibercept | 115 | |
| Overall Study | STARTED | mFOLFOX6 | 65 | |
| Overall Study | COMPLETED | mFOLFOX6 + Aflibercept | 99 | |
| Overall Study | COMPLETED | mFOLFOX6 | 61 | |
| Overall Study | NOT COMPLETED | mFOLFOX6 + Aflibercept | 16 | |
| Overall Study | NOT COMPLETED | mFOLFOX6 | 4 |
Source ClinicalTrials.gov
Adverse events96
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 | Asthenia | General disorders | mFOLFOX6 + Aflibercept | 65 | 115 | |
| other | Asthenia | General disorders | mFOLFOX6 | 38 | 65 | |
| other | Peripheral neuropathy | Nervous system disorders | mFOLFOX6 + Aflibercept | 48 | 115 | |
| other | Peripheral neuropathy | Nervous system disorders | mFOLFOX6 | 30 | 65 | |
| other | Diarrhoea | Gastrointestinal disorders | mFOLFOX6 + Aflibercept | 42 | 115 | |
| other | Diarrhoea | Gastrointestinal disorders | mFOLFOX6 | 22 | 65 | |
| other | Mucosal inflamation | Gastrointestinal disorders | mFOLFOX6 + Aflibercept | 48 | 115 | |
| other | Mucosal inflamation | Gastrointestinal disorders | mFOLFOX6 | 14 | 65 | |
| other | Nausea | General disorders | mFOLFOX6 + Aflibercept | 37 | 115 | |
| other | Nausea | General disorders | mFOLFOX6 | 23 | 65 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | mFOLFOX6 + Aflibercept | 12 | 115 |
| Total, all-cause mortality | mFOLFOX6 | 7 | 65 |
| Total, other adverse events | mFOLFOX6 + Aflibercept | 115 | 115 |
| Total, other adverse events | mFOLFOX6 | 65 | 65 |
| Total, serious adverse events | mFOLFOX6 + Aflibercept | 45 | 115 |
| Total, serious adverse events | mFOLFOX6 | 16 | 65 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31465088 | 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 |
|---|---|
| mFOLFOX6 + Aflibercept vs mFOLFOX6: deaths from any cause | Trial comparisons |
| mFOLFOX6 + Aflibercept vs mFOLFOX6: 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/NCT02340949
GET https://conductscience.org/api/trials/v1/NCT02340949/results?page=2