Trial · NCT01212822
Bevacizumab and Combination Chemotherapy Before Surgery in Treating Patients With Locally Advanced Esophageal or Stomach Cancer
NCT01212822, Phase 2, Completed, Fox Chase Cancer Center; results first posted 2022-09-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bevacizumab and Combination Chemotherapy Before Surgery in Treating Patients With Locally Advanced Esophageal or Stomach Cancer. Trials, record NCT01212822. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01212822
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab and Combination Chemotherapy Before Surgery in Treating Patients With Locally Advanced Esophageal or Stomach Cancer
- NCT number
- NCT01212822
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Fox Chase Cancer Center
- Conditions
Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Squamous Cell Carcinoma of the Esophagus, Stage IA Esophageal Cancer, Stage IA Gastric Cancer, Stage IB Esophageal Cancer, Stage IB Gastric Cancer, Stage IIA Esophageal Cancer, Stage IIA Gastric Cancer, Stage IIB Esophageal Cancer, Stage IIB Gastric Cancer, Stage IIIA Esophageal Cancer, Stage IIIA Gastric Cancer, Stage IIIB Esophageal Cancer, Stage IIIB Gastric Cancer, Stage IIIC Esophageal Cancer, Stage IIIC Gastric Cancer
- Interventions
- bevacizumab, oxaliplatin, leucovorin calcium, fluorouracil, therapeutic conventional surgery, laboratory biomarker analysis
- First posted
- 2010-10-01
- Last updated
- 2022-09-07
- Results first posted
- 2022-09-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival | 2 years | To investigate 2 year disease free survival in pts with resectable esophageal and GE junction cancer treated with perioperative bevaciumab and FOLFOX |
| Secondary | Complete and Partial Response to Neoadjuvant Therapy Based on the Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 3 years | To assess, by path examination after surgical resection, complete and partial response to neoadjuvant therapy. Characterized using proportions and 95% confidence intervals. |
| Secondary | Overall Survival | 4.5 years | Characterized using Kaplan-Meier curves. |
| Secondary | Progression Free Survival | 3 years | Characterized using Kaplan-Meier curves. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions and a 5 mm absolute increase, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Other | Change in Biomarker Levels | Baseline up to day of surgery | Means, medians, and standard deviations of the biomarker levels and change in biomarker levels within groups defined by response/resistance outcomes will be reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-free Survival | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Complete and Partial Response to Neoadjuvant Therapy Based on the Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 3 years | percent of patients | NUMBER | |
| SECONDARY | Overall Survival | 4.5 years | months | MEDIAN | |
| SECONDARY | Progression Free Survival | 3 years | One patient who was not evaluated for progression was excluded from PFS analysis | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Change in Biomarker Levels | Baseline up to day of surgery | Exploratory endpoint, data is not available for analyses |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival | Treatment (Bevacizumab, FOLFOX) | 4 | Participants | ||
| Complete and Partial Response to Neoadjuvant Therapy Based on the Response Evaluation Criteria in Solid Tumors (RECIST) | Treatment (Bevacizumab, FOLFOX) | 44.4 | 95% Confidence Interval 21.5 to 69.2 | percent of patients | |
| Overall Survival | Treatment (Bevacizumab, FOLFOX) | 26.0 | 95% Confidence Interval 23.7 to 51.4 | months | |
| Progression Free Survival | Treatment (Bevacizumab, FOLFOX) | 19.0 | 95% Confidence Interval 13.1 to NA | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Bevacizumab, FOLFOX) | 20 | |
| Overall Study | COMPLETED | Treatment (Bevacizumab, FOLFOX) | 20 | |
| Overall Study | NOT COMPLETED | Treatment (Bevacizumab, FOLFOX) | 0 |
Source ClinicalTrials.gov
Adverse events74
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 | Anemia | Blood and lymphatic system disorders | Treatment (Bevacizumab, FOLFOX) | 16 | 20 | |
| other | Neutrophil count decreased | Investigations | Treatment (Bevacizumab, FOLFOX) | 10 | 20 | |
| other | Platelet count decreased | Investigations | Treatment (Bevacizumab, FOLFOX) | 10 | 20 | |
| other | White blood cell decreased | Investigations | Treatment (Bevacizumab, FOLFOX) | 10 | 20 | |
| other | Fatigue | General disorders | Treatment (Bevacizumab, FOLFOX) | 17 | 20 | |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Treatment (Bevacizumab, FOLFOX) | 17 | 20 | |
| other | Nausea | Gastrointestinal disorders | Treatment (Bevacizumab, FOLFOX) | 10 | 20 | |
| other | Neuropathy/paresthesia | Nervous system disorders | Treatment (Bevacizumab, FOLFOX) | 13 | 20 | |
| other | Pain | General disorders | Treatment (Bevacizumab, FOLFOX) | 13 | 20 | |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Bevacizumab, FOLFOX) | 12 | 20 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Bevacizumab, FOLFOX) | 10 | 20 |
| Total, other adverse events | Treatment (Bevacizumab, FOLFOX) | 20 | 20 |
| Total, serious adverse events | Treatment (Bevacizumab, FOLFOX) | 11 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA006927 | Comprehensive Cancer Center Program at Fox Chase | WIEST, DAVID L. | RESEARCH INST OF FOX CHASE CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01212822
GET https://conductscience.org/api/trials/v1/NCT01212822/events?page=2