Trial · NCT01747551
FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer
NCT01747551, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2018-05-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer. Trials, record NCT01747551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01747551
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer
- NCT number
- NCT01747551
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Esophageal Cancer, Gastric Cancer
- Interventions
- Oxaliplatin, Leucovorin, Fluorouracil, Ziv-aflibercept
- First posted
- 2012-12-11
- Last updated
- 2020-02-10
- Results first posted
- 2018-05-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6-month Progression-free Survival (PFS) | Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patient follow-up was 6 months. | 6-month PFS is the percent probability of patients remaining alive and progression-free at 6-months from randomization estimated using Kaplan-Meier methods. PFS was measured as the time from randomization to 1st documented disease progression (PD) or death. Patients alive without PD were censored at the earliest of the date of last progression-free disease assessment or start of non-protocol therapy. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. |
| Secondary | Grade 4 Treatment-Related Toxicity Rate | Adverse events were collected each cycle on treatment. Patients received a median (range) treatment duration (months) of 6.9 (0-23.3) and 6.4 (0-43.9) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively. | The percentage of patients who experienced maximum grade 4 treatment-related adverse event based on CTCAEv4 as reported on case report forms. |
| Secondary | Objective Response Rate (ORR) | Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patients received a median (range) treatment duration (m) of 6.9 (0-23.3) and 6.4 (0-43.9) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively. | ORR was defined as the percentage of patients achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Duration of Objective Response | Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patient follow-up (months) median (range) was 14.5 (1.1-49.8) and 18.8 (0.6-49.8) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively. | Duration of response is the time from date of first documented confirmed objective response to date of first documented progressive disease. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6-month Progression-free Survival (PFS) | Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patient follow-up was 6 months. | The analysis dataset is comprised of all randomized patients. | percent probability | NUMBER |
| SECONDARY | Grade 4 Treatment-Related Toxicity Rate | Adverse events were collected each cycle on treatment. Patients received a median (range) treatment duration (months) of 6.9 (0-23.3) and 6.4 (0-43.9) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively. | percentage of participants | NUMBER | |
| SECONDARY | Objective Response Rate (ORR) | Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patients received a median (range) treatment duration (m) of 6.9 (0-23.3) and 6.4 (0-43.9) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively. | The analysis dataset is comprised of all patients with measurable disease at baseline. | percentage of patients | NUMBER |
| SECONDARY | Duration of Objective Response | Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patient follow-up (months) median (range) was 14.5 (1.1-49.8) and 18.8 (0.6-49.8) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively. | The analysis dataset is comprised of patients who achieved objective response except one patient on the mFOLFOX6+Placebo is missing data. | months | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6-month Progression-free Survival (PFS) | mFOLFOX6 + Ziv-aflibercept | 60.5 | 95% Confidence Interval 44.3 to 73.3 | percent probability | |
| 6-month Progression-free Survival (PFS) | mFOLFOX6 + Placebo | 57.1 | 95% Confidence Interval 33.8 to 74.9 | percent probability | |
| Grade 4 Treatment-Related Toxicity Rate | mFOLFOX6 + Ziv-aflibercept | 11.6 | 95% Confidence Interval 3.9 to 25.1 | percentage of participants | |
| Grade 4 Treatment-Related Toxicity Rate | mFOLFOX6 + Placebo | 9.5 | 95% Confidence Interval 1.2 to 30.4 | percentage of participants | |
| Objective Response Rate (ORR) | mFOLFOX6 + Ziv-aflibercept | 61.1 | 95% Confidence Interval 43.5 to 76.9 | percentage of patients | |
| Objective Response Rate (ORR) | mFOLFOX6 + Placebo | 75.0 | 95% Confidence Interval 47.6 to 97.2 | percentage of patients | |
| Duration of Objective Response | mFOLFOX6 + Ziv-aflibercept | 9.0 | Full Range 1.4 to 22.0 | months | |
| Duration of Objective Response | mFOLFOX6 + Placebo | 8.0 | Full Range 1.8 to 16.8 | months |
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 | mFOLFOX6 + Ziv-aflibercept | 43 | |
| Overall Study | STARTED | mFOLFOX6 + Placebo | 21 | |
| Overall Study | COMPLETED | mFOLFOX6 + Ziv-aflibercept | 0 | |
| Overall Study | COMPLETED | mFOLFOX6 + Placebo | 0 | |
| Overall Study | NOT COMPLETED | mFOLFOX6 + Ziv-aflibercept | 43 | |
| Overall Study | NOT COMPLETED | mFOLFOX6 + Placebo | 21 |
Source ClinicalTrials.gov
Adverse events434
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 | Abdominal distension | Gastrointestinal disorders | mFOLFOX6 + Ziv-aflibercept | 1 | 43 | |
| other | Abdominal distension | Gastrointestinal disorders | mFOLFOX6 + Placebo | 2 | 21 | |
| other | Abdominal pain | Gastrointestinal disorders | mFOLFOX6 + Ziv-aflibercept | 20 | 43 | |
| other | Abdominal pain | Gastrointestinal disorders | mFOLFOX6 + Placebo | 9 | 21 | |
| other | Acute kidney injury | Renal and urinary disorders | mFOLFOX6 + Ziv-aflibercept | 1 | 43 | |
| other | Acute kidney injury | Renal and urinary disorders | mFOLFOX6 + Placebo | 0 | 21 | |
| other | Alanine aminotransferase increased | Investigations | mFOLFOX6 + Ziv-aflibercept | 10 | 43 | |
| other | Alanine aminotransferase increased | Investigations | mFOLFOX6 + Placebo | 4 | 21 | |
| other | Alkaline phosphatase increased | Investigations | mFOLFOX6 + Ziv-aflibercept | 21 | 43 | |
| other | Alkaline phosphatase increased | Investigations | mFOLFOX6 + Placebo | 10 | 21 |
1 to 10 of 434Source ClinicalTrials.gov
See all 434 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | mFOLFOX6 + Ziv-aflibercept | 2 | 43 |
| Total, all-cause mortality | mFOLFOX6 + Placebo | 0 | 21 |
| Total, other adverse events | mFOLFOX6 + Ziv-aflibercept | 43 | 43 |
| Total, other adverse events | mFOLFOX6 + Placebo | 21 | 21 |
| Total, serious adverse events | mFOLFOX6 + Ziv-aflibercept | 34 | 43 |
| Total, serious adverse events | mFOLFOX6 + Placebo | 9 | 21 |
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 |
|---|---|
| mFOLFOX6 + Ziv-aflibercept vs mFOLFOX6 + Placebo: deaths from any cause | Trial comparisons |
| mFOLFOX6 + Ziv-aflibercept vs mFOLFOX6 + Placebo: 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/NCT01747551
GET https://conductscience.org/api/trials/v1/NCT01747551/events?page=2