Trial · NCT02037048
FOLFOX-6 Induction Chemotherapy Followed by Esophagectomy and Post-operative Chemoradiotherapy in Patients With Esophageal Adenocarcinoma
NCT02037048, Phase 2, Unknown, Case Comprehensive Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FOLFOX-6 Induction Chemotherapy Followed by Esophagectomy and Post-operative Chemoradiotherapy in Patients With Esophageal Adenocarcinoma. Trials, record NCT02037048. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02037048
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FOLFOX-6 Induction Chemotherapy Followed by Esophagectomy and Post-operative Chemoradiotherapy in Patients With Esophageal Adenocarcinoma
- NCT number
- NCT02037048
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Case Comprehensive Cancer Center
- Conditions
Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Adenocarcinoma of the Gastric Cardia, Stage IIIA Esophageal Cancer, Stage IIIB Esophageal Cancer, Stage IIIC Esophageal Cancer
- Interventions
- oxaliplatin, leucovorin calcium, fluorouracil, therapeutic conventional surgery, radiation therapy, carboplatin, paclitaxel
- First posted
- 2014-01-15
- Last updated
- 2024-01-08
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence Free Survival (RFS) compared to historical averages | 1 year | Compare the number of study patients who achieved RFS with \>50% remaining viable tumor after response adapted adjuvant chemoradiotherapy to historical data among patients with \>50% viable tumor after induction chemotherapy. A once sided test (p\<=0.05) will be used to describe significance of change. |
| Secondary | Symptomatic response | Up to 5 years | Symptomatic response is defined as improvement in dysphagia by 1 grade from baseline. Level 1 - No dysphagia. Level 2 - Minimal dysphagia, able to swallow liquids and most solid foods, experiencing occasional difficulty. Level 3 - Moderate dysphagia, able to swallow liquids and very soft foods. Level 4 - Severe dysphagia, unable to swallow liquids or solids. Significance of change will be calculated using 95% confidence intervals. |
| Secondary | Endoscopic response | Up to 5 years | Complete response = no residual abnormality (cyT0N0-Stage 0). Partial response = any improvement in the clinically determined T or N stage (without reciprocal deterioration in T or N) when compared to the pretreatment clinical stage as assessed by EGD/EUS. Stable disease = no change in the clinical T or N stage when compared to the pretreatment assessment. Progressive disease = any increase in the T or N stage (irrespective of any reciprocal improvement in the T or N stage) when compared to the pretreatment clinical stage as assessed by EGD/EUS. Endoscopic response will be estimated using exact 95% confidence intervals. |
| Secondary | Pathologic response | Up to 5 years | A positive pathologic response (+PR) will be defined as ≤ 50% residual tumor cells remaining. A negative pathologic response (-PR) will be defined as \>50% residual tumor cells remaining. Pathologic response will be described using exact 95% confidence intervals. |
| Secondary | Complete resection (R0) rate | Up to 5 years | R0 resection is defined as the resection of all gross and microscopic tumor. R0 resections will be estimated using exact 95% confidence intervals. |
| Secondary | Incidence of toxicity | Up to 5 years | Toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The number of toxicities will be estimated using exact 95% confidence intervals. |
| Secondary | RFS within study patients | Time from start of treatment until first recurrence or death from any cause, assessed up to 5 years | RFS will be compared between patients with ≤ 50% and \> 50% viable tumor using the log-rank test. Outcomes will be calculated relative to the start of therapy. Log rank tests will be used to estimate the hazard ratio for RFS for patients with \> 50% viable tumor relative to those with ≤ 50%. If there are a sufficient number of events, multivariable Cox analysis will be done to adjust for other prognostic factors. |
| Secondary | OS | Time from start of treatment until death due to any cause, assessed up to 5 years | OS will be compared between patients with ≤ 50% and \> 50% viable tumor using the log-rank test. Outcomes will be calculated relative to the start of therapy. Log rank tests will be used to estimate the hazard ratio for OS for patients with \> 50% viable tumor relative to those with ≤ 50%. If there are a sufficient number of events, multivariable Cox analysis will be done to adjust for other prognostic factors. |
| Secondary | Rate of Distant Metastatic Control (DMC) | Up to 5 years | Kaplan Meier analysis will be used to estimate distant recurrence |
| Secondary | Loco-regional control (LRC) | Up to 5 years | Kaplan-Meier analysis will be used to estimate local recurrence |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA043703 | Case Comprehensive Cancer Center Support Grant | SCHWARTZ, GARY K | CASE WESTERN RESERVE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1987 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/NCT02037048
GET https://conductscience.org/api/trials/v1/NCT02037048/registered